Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care
Diagnosis and Treatment of Adults with Osteoporotic Vertebral Fractures
Recommendations:
Medical Treatments
The literature search did not include an in-depth review of adverse effects of each of the medications studied. The ultimate judgment regarding any specific medication or treatment is to be made by the provider and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution.
Medical Treatment Question 1: How do nonpharmacologic treatments (eg, bracing, physical therapy, acupuncture, massage, cannabis, exercise, etc.) compare in terms of reducing severity and duration of pain and disability in osteoporotic vertebral compression fractures?
Bracing may be considered for adults for osteoporotic vertebral compression fractures. There is insufficient evidence to recommend a specific type of brace.
Grade of Recommendation: C
In a prospective comparative study, Kato et al1 compared the preventive effect of rigid brace and soft brace treatments for patients with OVCF. The authors concluded that “the 12-week rigid-brace treatment for acute vertebral compression fractures did not result in statistically greater prevention of spinal deformity, better QOL, or lesser back pain than soft-brace treatment at 48 weeks. Therefore, the routine use of a custom-made rigid brace for acute vertebral compression fractures is not justified.” This paper provides Level II evidence that in women with acute OVCFs treated with either a rigid custom-made back support or soft support, there was no significant difference in clinical and radiographic outcomes at 48 weeks. In a prospective comparative study, Meccariello et al2 investigated the effectiveness and safety of a 3-point orthosis brace and a dynamic corset brace in treating OVCFs. The authors concluded that compared to 3-point orthosis, patients treated with dynamic orthosis had a greater reduction in pain and a greater improvement in quality of life and respiratory function, with equal effectiveness in stabilizing the fracture, and fewer complications. This paper provides Level II evidence that in patients with acute back pain due to acute OVCF, a dynamic corset produced statistically significant better clinical outcomes than a 3-point brace. In a prospective comparative study, Li et al3 studied the effectiveness of soft lumbar orthosis versus a specific orthosis made of metal with soft padding on patients with an OVCF, at the subacute stage. The authors concluded that “The effect of the two types of spinal orthoses on the pain level reduction and functional mobility level gain did not show significant difference (p > 0.05) at the subacute stage.” The workgroup downgraded this potential Level II paper due to nonconsecutive and nonmasked patients, nonmasked reviewers, lack of subgroup analysis, and the diagnostic method not being stated. This paper provides Level III evidence that in female patients with acute OVCF treated either with a soft lumbar orthosis vs a specific orthosis made of metal with soft padding after 3 weeks, there was no difference in clinical outcomes. References: 1. Kato T, Inose H, Ichimura S, et al. Comparison of Rigid and Soft-Brace Treatments for Acute Osteoporotic Vertebral Compression Fracture: A Prospective, Randomized, Multicenter Study. J Clin Med. 2019;8(2):198. Published 2019 Feb 6. doi:10.3390/jcm8020198 2. Meccariello L, Muzii VF, Falzarano G, et al. Dynamic corset versus three-point brace in the treatment of osteoporotic compression fractures of the thoracic and lumbar spine: a prospective, comparative study. Aging Clin Exp Res. 2017;29(3):443-449. doi:10.1007/s40520-016-0602-x 3. Li M, Law SW, Cheng J, Kee HM, Wong MS. A comparison study on the efficacy of SpinoMed® and soft lumbar orthosis for osteoporotic vertebral fracture. Prosthet Orthot Int. 2015;39(4):270-276. doi:10.1177/0309364614528204
There is insufficient evidence to make a recommendation for or against strict immobilization in adults with acute osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective case series study, Weerink et al1 aimed to assess the medical management of geriatric patients with a vertebral fracture. The authors concluded that the treatment of older adults “with a fracture involving both middle and anterior columns may be altered from immobilization to mobilization in the future.” The work group downgraded this potential Level III paper due to nonconsecutive, nonmasked, and nonrandomized patients, nonmasked reviewers, less than 80% follow-up, lack of subgroup analysis, and no validated outcome measures being used. This paper provides IV evidence that, early mobilization of older adults with acute OVCF results in functional outcomes comparable to immobilization at 3-month follow-up with less risk of complications. References: 1. Weerink LB, Folbert EC, Kraai M, Smit RS, Hegeman JH, van der Velde D. Thoracolumbar spine fractures in the geriatric fracture center: early ambulation leads to good results on short term and is a successful and safe alternative compared to immobilization in elderly patients with two-column vertebral fractures. Geriatr Orthop Surg Rehabil. 2014;5(2):43-49. doi:10.1177/2151458514524053
There is insufficient evidence to make a recommendation for or against taping in the management of acute osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective randomized control trial study, Palmer et al1 examined the effects of postural taping on the quality of life, pain, and function in relation to usual care following an OVCF. The authors concluded that “the postural taping device has demonstrated the potential to improve pain, function and QoL.” The work group downgraded this potential Level II paper due to nonconsecutive and nonmasked patients, nonmasked reviewers, and a small sample size. This paper provides Level III evidence that the use of taping device has potential to improve pain and function in patients with OVCF as compared to usual care. References: 1. Palmer S, Barnett S, Cramp M, Berry A, Thomas A, Clark EM. Effects of postural taping on pain, function and quality of life following osteoporotic vertebral fractures-A feasibility trial. Musculoskeletal Care. 2018;16(3):345-352. doi:10.1002/msc.1350
FLASK Future Directions for Research
The work group recommends high-quality studies in patients with acute osteoporotic vertebral compression fractures to:
- Evaluate the effectiveness of bracing vs no bracing in patients with osteoporotic vertebral compression fractures.
- Compare different bracing techniques.
- Evaluate the effectiveness and comparison of other nonpharmacologic treatments (physical therapy, acupuncture, massage, cannabis, exercise etc.).
Medical Treatment Question 2: Do restrictions on patient activity alter outcomes in patients with acute osteoporotic vertebral compression fractures?
There is insufficient evidence to make a recommendation for or against immobilization or early activity in adults with acute osteoporotic vertebral compression fracture.
Grade of Recommendation: I
In a retrospective case series study, Weerink et al1 assessed the medical management of older adult patients with a vertebral fracture. The authors concluded that the treatment of older adults “with a fracture involving both middle and anterior columns may be altered from immobilization to mobilization in the future.” The work group downgraded this potential Level III paper due to nonconsecutive, nonmasked, and nonrandomized patients, nonmasked reviewers, less than 80% follow-up, lack of subgroup analysis, and no validated outcome measures being used. This paper provides Level IV evidence that immobilization and early ambulation leads to similar outcomes in older adults with 2-column vertebral fractures. References 1. Weerink LB, Folbert EC, Kraai M, Smit RS, Hegeman JH, van der Velde D. Thoracolumbar spine fractures in the geriatric fracture center: early ambulation leads to good results on short term and is a successful and safe alternative compared to immobilization in elderly patients with two-column vertebral fractures. Geriatr Orthop Surg Rehabil. 2014;5(2):43-49. doi:10.1177/2151458514524053
FLASK Future Directions for Research
The work group recommends high-quality prospective studies to evaluate whether immobilization or early activity should be recommended in patients with acute osteoporotic vertebral compression fractures.
Medical Treatment Question 3: Which pharmacologic treatments are effective in improving outcomes in acute osteoporotic vertebral compression fractures?
Calcitonin is suggested for relief of pain in adults with acute osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a prospective randomized control trial study, Combe et al1 evaluated the safety and effectiveness of nasal spray and subcutaneous formulations of salmon calcitonin in patients with OVCF. The authors concluded that “a 30-day course with 200 IU/day of intranasal salmon calcitonin (INSCT) demonstrated an equivalence with a 30-day course with 50 IU/day of subcutaneous salmon calcitonin (SCSCT).” The work group downgraded this potential Level I paper due to nonconsecutive patients, lack of subgroup analysis, an X-ray-based analysis, and there being no real control group. This paper provides Level II evidence that, subcutaneous and intranasal calcitonin produce comparable effects in pain reduction in patients with acute OVF. In a prospective randomized control trial study, Laroche et al2 compared the pain-relieving effectiveness of IV pamidronate and synthetic human calcitonin in patients with osteoporotic vertebral fractures. The authors concluded that there is “no superiority of PAM over CT in a single infusion in the treatment of painful recent benign vertebral compression. Because it is ten times less costly, CT should thus be preferentially used.” The work group downgraded this potential Level I paper due to small sample size. This paper provides Level II evidence that, in the treatment of pain in patient with acute OVCF, there is no difference in short-term outcome between single infusions of pamidronate vs calcitonin. In a prospective randomized control trial study, Lyritis et al3 investigated the pain-relieving effectiveness of calcitonin suppositories (200 IU) versus bedrest and paracetamol for patients with osteoporotic vertebral fractures. The authors concluded that “salmon calcitonin suppositories (200 IU daily) caused a dramatic decrease in spinal pain in patients with recent osteoporotic vertebral fractures and influenced the early mobilization and the gradual restoration of their locomotor functions.” The work group downgraded this potential Level I paper due to nonconsecutive, small sample size. This paper provides Level II evidence that, in patients with acute OVCF, salmon calcitonin suppositories may improve pain and allow earlier mobilization than placebo treated patients. In a prospective randomized control trial study, Lyritis et al4 studied the effectiveness of relieving postosteoporotic vertebral crush fracture pain using salmon calcitonin spray (200 IU). The authors concluded that “nasal salmon calcitonin in a daily dose of 200 IU had an adequate analgesic effect and facilitated mobilization of patients suffering from a recent osteoporotic vertebral fracture.” The work group downgraded this potential Level I paper due to nonconsecutive patients. This paper provides Level II evidence that, in patients with painful acute OVCFs, nasal salmon calcitonin may provide significant pain relief and promote earlier mobilization. In a prospective randomized control trial study, Lyritis et al5 examined the pain-relieving effectiveness of salmon calcitonin injections in patients with osteoporotic vertebral fractures, more specifically by evaluating the effect on the facilitation of early mobilization. The authors concluded that “calcitonin exerts a beneficial effect on back pain following a vertebral crush fracture.” The work group downgraded this potential Level I paper due to nonconsecutive patients. This paper provides Level II evidence that, in patients with acute OVCF, injectable calcitonin provided significant pain relief and allowed earlier mobilization. In a prospective randomized control trial study, Pun et al6 studied the nasal administration of salmon calcitonin in the treatment of patients with osteoporotic vertebral fractures. The authors concluded that “salmon calcitonin, which is easily administered intranasally, can significantly reduce the pain of osteoporotic collapse of vertebrae.” The work group downgraded this potential Level I paper due to nonconsecutive patients and small sample size. This paper provides Level II evidence that, in patients with acute VCFs, daily intranasal calcitonin significantly reduces pain and analgesic consumption in comparison to placebo treated patients. In a prospective randomized controlled trial study, Tanaka et al7 aimed to clarify the effects of monotherapy and combination therapy, with calcitonin (elcatonin) and bisphosphonate (minodronic acid hydrate), on the early treatment of vertebral fractures in osteoporotic patients. The authors concluded that “combination therapy with elcatonin and minodronic acid hydrate appears to be an effective treatment for osteoporosis patients with lower back pain, caused by fresh vertebral fractures.” The work group downgraded this potential Level I paper due to nonconsecutive patients. This paper provides Level II evidence that in patients with osteoporosis and acute VCFs, the combination of calcitonin and minodronic acid produced both better pain relief than either monotherapy. In a prospective randomized controlled trial study, Tanaka et al8 analyzed changes in pain, ADL, QOL, bone resorption, BMD, and fracture healing in patients with new osteoporotic vertebral fractures who were given a treatment of intramuscular injections of elcatonin or NSAID in combination with VD3 analogue. The authors concluded that “in patients with new vertebral fractures, elcatonin was shown to alleviate pain as effectively as a combined nonsteroidal anti-inflammatory drug (NSAID) + vitamin D3 (VD3) regimen immediately after starting the treatment, and more effectively in the later stages, thereby improving ADL and QOL. Moreover, even though elcatonin inhibited bone resorption more effectively than NSAID and VD3 and prevented decreases in BMD at other sites, it did not hinder fracture healing. These results suggest that elcatonin significantly alleviated pain, inhibited bone resorption, and improved ADL, QOL, and BMD compared with NSAID + VD3.” The work group downgraded this potential Level I paper due to nonconsecutive patients. This paper provides Level II evidence that in patients with acute VCFs Calcitonin was superior to relieving pain to an NSAID after 2 weeks and led to better QOL and ability to perform ADLs at 1 and 3 months.
References: 1. Combe B, Cohen C, Aubin F. Equivalence of nasal spray and subcutaneous formulations of salmon calcitonin. Calcif Tissue Int. 1997;61:10-5 2. Laroche M, Cantogrel S, Jamard B, et al. Comparison of the analgesic efficacy of pamidronate and synthetic human calcitonin in osteoporotic vertebral fractures: a double-blind controlled study. Clin Rheumatol. 2006;25(5):683-686. doi:10.1007/s10067-005-0159-0 3. Lyritis GP, Ioannidis GV, Karachalios T, et al. Analgesic effect of salmon calcitonin suppositories in patients with acute pain due to recent osteoporotic vertebral crush fractures: a prospective double-blind, randomized, placebo-controlled clinical study. Clin J Pain. 1999;15(4):284-289. doi:10.1097/00002508-199912000-00004 4. Lyritis GP, Paspati I, Karachalios T, Ioakimidis D, Skarantavos G, Lyritis PG. Pain relief from nasal salmon calcitonin in osteoporotic vertebral crush fractures. A double blind, placebo-controlled clinical study. Acta Orthop Scand Suppl. 1997;275:112-114. doi:10.1080/17453674.1997.11744761 5. Lyritis GP, Tsakalakos N, Magiasis B, Karachalios T, Yiatzides A, Tsekoura M. Analgesic effect of salmon calcitonin in osteoporotic vertebral fractures: a double-blind placebo-controlled clinical study. Calcif Tissue Int. 1991;49(6):369-372. doi:10.1007/BF02555844 6. Pun KK, Chan LW. Analgesic effect of intranasal salmon calcitonin in the treatment of osteoporotic vertebral fractures. Clin Ther. 1989;11(2):205-209. 7. Tanaka S, Yoshida A, Kono S, Ito M. Effectiveness of monotherapy and combined therapy with calcitonin and minodronic acid hydrate, a bisphosphonate, for early treatment in patients with new vertebral fractures: An open-label, randomized, parallel-group study. J Orthop Sci. 2017;22(3):536-541. doi:10.1016/j.jos.2016.12.021 8. Tanaka S, Yoshida A, Kono S, Oguma T, Hasegawa K, Ito M. Effectiveness of elcatonin for alleviating pain and inhibiting bone resorption in patients with osteoporotic vertebral fractures. J Bone Miner Metab. 2017;35(5):544-553. doi:10.1007/s00774-016-0791-6
Teriparatide is suggested for the relief of pain and improvement in quality of life in adults with acute osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a prospective randomized control trial study, Ikeda et al1 compared the treatment of weekly teriparatide and alendronate in women with new osteoporotic vertebral fractures (within one week after the onset of the fracture) by evaluating the effects on improvement in quality of life (QOL), inhibition of vertebral collapse, and delayed union. The authors concluded that “the effects of the weekly formulation of TPTD on inhibition of vertebral collapse, improvement in BMD, promotion of bone union, and relief of pain were comparable to the effects of ALN in female patients who sustained new osteoporotic vertebral fractures within 1 week. However, the TPTD group showed significant improvement in QOL at week 12 compared with the ALN group, which may reflect the improvement of components of QOL other than pain.” This paper provides Level I evidence that in patients with new OVCFs, weekly teriparatide is superior to alendronate in improving QOL at 12 weeks. In a prospective randomized control trial study, Shigenobu et al2 examined the impact of BP and weekly TPTD in treating patients with new spinal compression fractures, by evaluating the patient’s QOL and postfracture pain. The authors concluded that “weekly TPTD and BP both reduced back pain. In addition, in terms of QOL and fracture healing, weekly TPTD tended to improve both conditions faster than BP.” The work group downgraded this potential Level I paper due to nonconsecutive patients. This paper provides Level II evidence that in patients with acute VCFs, weekly teriparatide is superior to bisphosphonates in improving early rate of fracture healing, pain, and quality of life. In a prospective randomized control trial study, Armingeat et al3 studied the impact of intravenous pamidronate and a placebo (isotonic saline solution) on pain relief in patients with recent osteoporotic vertebral compression fractures. The authors concluded that “pamidronate provides rapid and sustained pain relief in patients with acute painful osteoporotic VCF and is well tolerated.” The work group downgraded this potential Level I paper due to small sample size. This paper provides Level II evidence that IV pamidronate is effective and well tolerated for treating acute OVCF. In a prospective case series study, Ma et al4 compared the 3-month therapeutic effects of TPTD and PVP on postmenopausal woman with acute OVCF. The authors concluded that “TPTD conservative treatment obtained similar therapeutic effects but cost less than PVP in terms of treating acute OVC.” The work group downgraded this potential Level II paper due to selection bias. This paper provides Level III evidence that in patients with OVCF, teriparatide produces significant improvement in pain and QoL at 3 months comparable to alendronate plus PVP and may be more cost effective. In a retrospective comparative study, Min et al5 analyzed the effects of different antiosteoporosis medications on radiological and clinical outcomes in patients after experiencing an acute osteoporotic spinal fracture. The authors concluded that “Different anti-osteoporosis medications presented different clinical and radiological results after acute OVCFs. The use of anabolic agent significantly enhanced fracture healing, reduced progressive collapse, and presented better clinical outcomes. Proper selection of medication might improve initial management of acute OSFs.” This paper provides Level III evidence that TPTD may improve fracture healing and produce better clinical outcomes compared to BP. In a prospective comparative study, Rovetta et al6 aimed to determine the outcomes of patients who took disodium clodronate when treating an osteoporotic vertebral fracture with patients who took acetaminophen by evaluating the correlation between pain duration and intensity. The authors concluded that “the use of disodium -clodronate was associated with a reduction in the number of days the patients experienced severe pain, which suggests that disodium-clodronate is a first line drug in the treatment of recent vertebral crush.” The work group downgraded this potential Level II paper due to small sample size. This paper provides Level III evidence that in patients with acute VCF, IV clodronate may produce significant reduction of pain in comparison to acetaminophen. In a prospective comparative study, Rovetta et al7 evaluated the effect of intravenous disodium clodronate on acute pain caused by OVCF. The authors concluded that “the treatment of highly painful vertebral fractures with IV disodium clodronate is more effective in producing gradual pain remission than paracetamol.” The work group downgraded this potential Level II paper due to nonrandomized and nonmasked patients, nonmasked reviewers, small sample size, and an X-ray-based diagnosis. This paper provides Level III evidence that in patients with acute VCF, IV clodronate may produce significant reduction of pain in comparison to acetaminophen. In a retrospective comparative study, Zheng et al8 investigated the clinical effectiveness of zoledronic acid combined with percutaneous kyphoplasty on the treatment of patients with osteoporotic vertebral body compression fractures. The authors concluded that “zoledronic acid, combined with percutaneous kyphoplasty can improve the therapeutic efficacy of OVCF after surgery, which provides new insights for the further treatment of OVCF in clinical practice.” This paper provides Level III evidence that in patients with acute OVCFs, the addition of Zoledronate after a PKP significantly improves pain, reduces risk of recurrent fracture at 1, 3, 6, and 12 months. References: 1. Ikeda S, Nakamura E, Narusawa K, et al. Comparison of once-weekly teriparatide and alendronate against new osteoporotic vertebral fractures at week 12. J Bone Miner Metab. 2020;38(1):44-53. doi:10.1007/s00774-019-01023-x 2. Shigenobu K, Hashimoto T, Kanayama M, Ohha H, Yamane S. The efficacy of osteoporotic treatment in patients with new spinal vertebral compression fracture pain, ADL, QOL, bone metabolism and fracture-healing - In comparison with weekly teriparatide with bisphosphonate. Bone Rep. 2019;11:100217. doi:10.1016/j.bonr.2019.100217. 3. Armingeat T, Brondino R, Pham T, Legré V, Lafforgue P. Intravenous pamidronate for pain relief in recent osteoporotic vertebral compression fracture: a randomized double-blind controlled study. Osteoporos Int. 2006;17(11):1659-1665. doi:10.1007/s00198-006-0169-z 4. Ma Y, Wu X, Xiao X, et al. Effects of teriparatide versus percutaneous vertebroplasty on pain relief, quality of life and cost-effectiveness in postmenopausal females with acute osteoporotic vertebral compression fracture: A prospective cohort study. Bone. 2020;131:115154. doi:10.1016/j.bone.2019.115154 5. Min HK, Ahn JH, Ha KY, et al. Effects of anti-osteoporosis medications on radiological and clinical results after acute osteoporotic spinal fractures: a retrospective analysis of prospectively designed study. Osteoporos Int. 2019;30(11):2249-2256. doi:10.1007/s00198-019-05125-0 6. Rovetta G, Maggiani G, Molfetta L, Monteforte P. One-month follow-up of patients treated by intravenous clodronate for acute pain induced by osteoporotic vertebral fracture. Drugs Exp Clin Res. 2001;27(2):77-81. 7. Rovetta G, Monteforte P, Balestra V. Intravenous clodronate for acute pain induced by osteoporotic vertebral fracture. Drugs Exp Clin Res. 2000;26(1):25-30. 8. Zheng H, Li H, Zhang J, et al. The effect of zoledronic acid combined with percutaneous kyphoplasty on the treatment of osteoporotic vertebral body compression fractures in patients. J Biomater Tissue Eng. 2019;9(7):1008-1013
Bisphosphonates are suggested for relief of pain and improvement in quality of life in adults with acute osteoporotic vertebral compression fracture but are inferior to teriparatide.
Grade of Recommendation: B
In a prospective randomized control trial study, Ikeda et al1 compared the treatment of weekly teriparatide and alendronate in women with new osteoporotic vertebral fractures (within one week after the onset of the fracture) by evaluating the effects on improvement in quality of life, inhibition of vertebral collapse, and delayed union. The authors concluded that “the effects of the weekly formulation of TPTD on inhibition of vertebral collapse, improvement in BMD, promotion of bone union, and relief of pain were comparable to the effects of ALN in female patients who sustained new osteoporotic vertebral fractures within 1 week. However, the TPTD group showed significant improvement in QOL at week 12 compared with the ALN group, which may reflect the improvement of components of QOL other than pain.” This paper provides Level I evidence that in patients with new OVCFs, weekly teriparatide is superior to alendronate in improving QOL at 12 weeks. In a prospective randomized control trial study, Shigenobu et al2 examined the impact of BP and weekly TPTD in treating patients with new spinal compression fractures, by evaluating the patient’s quality of life (QOL) and postfracture pain. The authors concluded that “weekly TPTD and BP both reduced back pain. In addition, in terms of QOL and fracture healing, weekly TPTD tended to improve both conditions faster than BP.” The work group downgraded this potential Level I paper due to nonconsecutive patients. This paper provides Level II evidence that in patients with acute VCFs, weekly teriparatide is superior to bisphosphonates in improving early rate of fracture healing, pain, and quality of life. In a prospective randomized control trial study, Armingeat et al3 studied the impact of intravenous pamidronate and a placebo (isotonic saline solution) on pain relief in patients with recent osteoporotic vertebral compression fractures. The authors concluded that “pamidronate provides rapid and sustained pain relief in patients with acute painful osteoporotic VCF and is well tolerated.” The work group downgraded this potential Level I paper due to small sample size. This paper provides Level II evidence that IV pamidronate is effective and well tolerated for treating acute OVCF. In a prospective case series study, Ma et al4 compared the 3-month therapeutic effects of TPTD and PVP on postmenopausal woman with acute OVCF. The authors concluded that “TPTD conservative treatment obtained similar therapeutic effects but cost less than PVP in terms of treating acute OVC.” The work group downgraded this potential Level II paper due to selection bias. This paper provides Level III evidence that in patients with OVCF, teriparatide produces significant improvement in pain and QoL at 3 months comparable to alendronate plus PVP and may be more cost effective. In a retrospective comparative study, Min et al5 analyzed the effects of different antiosteoporosis medications on radiological and clinical outcomes in patients after experiencing an acute osteoporotic spinal fracture. The authors concluded that “Different anti-osteoporosis medications presented different clinical and radiological results after acute OVCFs. The use of anabolic agent significantly enhanced fracture healing, reduced progressive collapse, and presented better clinical outcomes. Proper selection of medication might improve initial management of acute OSFs.” This paper provides Level III evidence that TPTD may improve fracture healing and produce better clinical outcomes compared to BP. In a prospective comparative study, Rovetta et al6 aimed to determine the of outcomes of patients who took disodium clodronate when treating an osteoporotic vertebral fracture with patients who took acetaminophen by evaluating the correlation between pain duration and intensity. The authors concluded that “the use of disodium -clodronate was associated with a reduction in the number of days the patients experienced severe pain, which suggests that disodium-clodronate is a first line drug in the treatment of recent vertebral crush.” The work group downgraded this potential Level II paper due to small sample size. This paper provides Level III evidence that in patients with acute VCF, IV clodronate may produce significant reduction of pain in comparison to acetaminophen. In a prospective comparative study, Rovetta et al7 evaluated the effect of intravenous disodium clodronate on acute pain caused by OVCF. The authors concluded that “the treatment of highly painful vertebral fractures with IV disodium clodronate is more effective in producing gradual pain remission than paracetamol.” The work group downgraded this potential Level II paper due to nonrandomized and nonmasked patients, nonmasked reviewers, small sample size, and an X-ray-based diagnosis. This paper provides Level III evidence that in patients with acute VCF, IV clodronate may produce significant reduction of pain in comparison to acetaminophen. In a retrospective comparative study, Zheng et al8 investigated the clinical effectiveness of zoledronic acid combined with percutaneous kyphoplasty on the treatment of patients with osteoporotic vertebral body compression fractures. The authors concluded that “zoledronic acid, combined with percutaneous kyphoplasty can improve the therapeutic efficacy of OVCF after surgery, which provides new insights for the further treatment of OVCF in clinical practice.” This paper provides Level III evidence that in in patients with acute OVCFs, the addition of Zoledronate after a PKP significantly improves pain, reduces risk of recurrent fracture at 1, 3, 6, and 12 months. References: 1. Ikeda S, Nakamura E, Narusawa K, et al. Comparison of once-weekly teriparatide and alendronate against new osteoporotic vertebral fractures at week 12. J Bone Miner Metab. 2020;38(1):44-53. doi:10.1007/s00774-019-01023-x 2. Shigenobu K, Hashimoto T, Kanayama M, Ohha H, Yamane S. The efficacy of osteoporotic treatment in patients with new spinal vertebral compression fracture pain, ADL, QOL, bone metabolism and fracture-healing - In comparison with weekly teriparatide with bisphosphonate. Bone Rep. 2019;11:100217. doi:10.1016/j.bonr.2019.100217. 3. Armingeat T, Brondino R, Pham T, Legré V, Lafforgue P. Intravenous pamidronate for pain relief in recent osteoporotic vertebral compression fracture: a randomized double-blind controlled study. Osteoporos Int. 2006;17(11):1659-1665. doi:10.1007/s00198-006-0169-z 4. Ma Y, Wu X, Xiao X, et al. Effects of teriparatide versus percutaneous vertebroplasty on pain relief, quality of life and cost-effectiveness in postmenopausal females with acute osteoporotic vertebral compression fracture: A prospective cohort study. Bone. 2020;131:115154. doi:10.1016/j.bone.2019.115154 5. Min HK, Ahn JH, Ha KY, et al. Effects of anti-osteoporosis medications on radiological and clinical results after acute osteoporotic spinal fractures: a retrospective analysis of prospectively designed study. Osteoporos Int. 2019;30(11):2249-2256. doi:10.1007/s00198-019-05125-0 6. Rovetta G, Maggiani G, Molfetta L, Monteforte P. One-month follow-up of patients treated by intravenous clodronate for acute pain induced by osteoporotic vertebral fracture. Drugs Exp Clin Res. 2001;27(2):77-81. 7. Rovetta G, Monteforte P, Balestra V. Intravenous clodronate for acute pain induced by osteoporotic vertebral fracture. Drugs Exp Clin Res. 2000;26(1):25-30. 8. Zheng H, Li H, Zhang J, et al. The effect of zoledronic acid combined with percutaneous kyphoplasty on the treatment of osteoporotic vertebral body compression fractures in patients. J Biomater Tissue Eng. 2019;9(7):1008-1013
There is insufficient evidence to make a recommendation for or against denosumab for relief of pain in adults with acute osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Tetsunaga et al1 evaluated and compared the effects of denosumab and alendronate treatment on pain relief in patients with a fresh osteoporotic vertebral fracture. The authors concluded that “Denosumab enabled earlier pain relief than alendronate and avoided catastrophizing in patients with osteoporotic vertebral fractures after 6 months of treatment.” This paper provides Level III evidence that in patients with acute OVCFs, denosumab provides faster pain relief than alendronate and avoided catastrophizing at 6 months.
References:
1. Tetsunaga T, Tetsunaga T, Nishida K, et al. Denosumab and alendronate treatment in patients with back pain due to fresh osteoporotic vertebral fractures. J Orthop Sci. 2017;22(2):230-236. doi:10.1016/j.jos.2016.11.017
There is insufficient evidence to make a recommendation for or against fentanyl for relief of pain in adults with acute osteoporotic vertebral compression fractures. Grade of Recommendation: I
In a retrospective case series study, Choi et al1 aimed to determine the prognostic factor and success rate of the conservative treatment method (low dose fentanyl transdermal patch) for vertebral compression fractures. The authors concluded that “The only statistically significant affecting factor for an unfavorable outcome was the use of a higher dose fentanyl patch. Our data inferred that the unresponsiveness to a low-dose fentanyl patch could be helpful to select patients necessary for percutaneous vertebroplasty or kyphoplasty.” This paper provides Level IV evidence that in patients with acute OVCF, low dose (12.5 μg) fentanyl patch may improve pain control. References: 1. Choi JH, Kang HD, Park JH, Gu BS, Jung SK, Oh SH. The Efficacy of Fentanyl Transdermal Patch as the First-Line Medicine for the Conservative Treatment of Osteoporotic Compression Fracture. Korean J Neurotrauma. 2017;13(2):130-136. doi:10.13004/kjnt.2017.13.2.130
FLASK Future Directions for Research
The workgroup recommends high-quality prospective studies of pharmacologic agents including opioids, calcitonin, teriparatide, bisphosphonates and denosumab in the treatment of painful acute osteoporotic vertebral compression fractures.
Medical Treatment Question 4: Does spinal manipulative treatment improve outcomes for patients with acute osteoporotic vertebral compression fractures?
A systematic review of the literature yielded no studies to adequately address this question.
FLASK Future Directions for Research
The work group recommends high-quality prospective studies evaluating the role of manual therapy in patients with acute osteoporotic vertebral compression fractures.
Medical Treatment Question 5: In patients presenting with symptomatic acute osteoporotic vertebral compression fractures, does medical treatment of the underlying bone loss improve long-term outcomes such as reduction in risk of future fragility fractures?
Teriparatide may be considered in adults with acute osteoporotic vertebral compression fractures to reduce the risk of future fragility fractures. Grade of Recommendation: C
In a prospective comparative study, Zhao et al1 compared the preventative effects of teriparatide and alendronate on the aggravation of spinal cord compromise in patients with new OVCF and surgical contraindications. The authors concluded that “in patients with neurological deficits following new unstable OVCF and with surgical contraindications, teriparatide was better than alendronate at improving the BMD and the bone turnover parameters, as well as preventing aggravation of spinal cord compromise.” This paper provides Level II evidence that teriparatide is superior to alendronate at 12 months in reducing the risk of new fractures in patients with unstable acute OVCFs. In a prospective case series study, Tu et al2 examined the short term and long-term effects of the treatment of teriparatide on patients with osteoporosis who have had a history of multiple and repeated new-onset OCVFs, while also assessing if this teriparatide can prevent new compression fractures. The authors concluded that “teriparatide can be used in patients who have repeated and multiple new onset painful VCF to avoid repeated vertebroplasty.” This paper provides Level IV evidence that in patients with repeated and acute VCFs, teriparatide may reduce the risk for future fractures and need for percutaneous vertebroplasty. References 1. Zhao Y, Xue R, Shi N, et al. Aggravation of spinal cord compromise following new osteoporotic vertebral compression fracture prevented by teriparatide in patients with surgical contraindications. Osteoporos Int. 2016;27(11):3309-3317. doi:10.1007/s00198-016-3651-2 2. Tu PH, Liu ZH, Lee ST, Chen JF. Treatment of repeated and multiple new-onset osteoporotic vertebral compression fractures with teriparatide. J Clin Neurosci. 2012;19(4):532-535. doi:10.1016/j.jocn.2011.04.048
Bisphosphonates may be considered in adults with acute osteoporotic vertebral compression fractures to reduce the risk of future fragility fractures. Grade of Recommendation: C
In a retrospective comparative study, Zheng et al1 studied the clinical effectiveness of zoledronic acid (Z) combined with PVP on the treatment of patients with OVCF. The authors concluded that “zoledronic acid, combined with percutaneous kyphoplasty can improve the therapeutic efficacy of OVCF after surgery, which provides new insights for the further treatment of OVCF in clinical practice.” This paper provides Level III evidence that in patients with acute OVCFs, in addition to PVP, Z significantly reduced recurring fracture risk and increased BMD. In a retrospective comparative study, Craig et al2 compared the efficacy and safety of intravenous zoledronic acid (ZOL) and oral alendronate (ALN) in osteoporotic patients with a low trauma fracture. The authors concluded that “ZOL and ALN both produce a significant increase in BMD and are well tolerated in patients with osteoporotic, low trauma fractures. Yearly ZOL provides a safe, convenient alternative to weekly oral bisphosphonates.” The work group downgraded this potential Level III paper due to nonconsecutive patients, no validated outcomes being measured, and the diagnostic method not being stated. This paper provides Level IV evidence that in patients with osteoporosis and an acute VCF, patients with OVCF treated with ALN had significantly fewer fractures at one year compared to ZOL. References 1. Zheng H, Li H, Zhang J, et al. The effect of zoledronic acid combined with percutaneous kyphoplasty on the treatment of osteoporotic vertebral body compression fractures in patients. J Biomater Tissue Eng. 2019;9(7):1008-1013 2. Craig SJ, Youssef PP, Vaile JH, Sullivan L, Bleasel JF. Intravenous zoledronic acid and oral alendronate in patients with a low trauma fracture: experience from an osteoporosis clinic. Intern Med J. 2011;41(2):186-190. doi:10.1111/j.1445-5994.2010.02198.x
FLASK Future Directions for Research
The work group recommends high-quality prospective studies evaluating the role of medical treatment of the underlying bone loss to improve long-term outcomes such as reduction in risk of future fragility fractures in patients presenting with symptomatic acute osteoporotic vertebral compression fractures.
Medical Treatment Question 6: Does spinal manipulative treatment improve outcomes for patients with acute osteoporotic vertebral compression fractures?
Does the involvement of multiple specialties in clinical management change the outcomes of acute osteoporotic vertebral compression fractures?
FLASK Future Directions for Research
The work group recommends high-quality studies evaluating the role of involvement of multiple specialties in clinical management on the outcomes in patients with acute osteoporotic vertebral compression fractures.