Which Treatments Reduce the Risk for Osteoporotic Fracture?

Raloxifene: A selective estrogen receptor modulator
An ongoing prospective, randomized study (2) of more than 7,700 women with osteoporosis showed that raloxifene (Evista), a selective estrogen receptor modulator (SERM), given for 3 years reduced the incidence of spine fractures by 30%. Treatment did not significantly reduce nonvertebral or hip fractures. Dosage is 60 mg/day.

Nasal salmon calcitonin
The effect of nasal salmon calcitonin (Miacalcin) on fracture reduction was evaluated in a 5-year prospective, randomized study (8) of more than 1,200 women. The drug reduced the risk of spine fracture by 36% in women receiving 200 IU. The study has been criticized, however, because it did not demonstrate a dose-response relationship, more than 60% of the patients withdrew from the study, and the investigators did not use intention-to treat as the basis of their statistical analysis.

Bisphosphonates
The bisphosphonates currently used to treat osteoporosis include etidronate, alendronate, and risedronate; however, only alendronate and risedronate are FDA-approved for this indication at present.

Etidronate (Didronel) has been shown to decrease spine fractures after 2 years of therapy, but this effect was lost after 3 years.

Alendronate (Fosamax) reduced vertebral, nonvertebral, and hip fractures by about 50% in prospective studies involving more than 10,000 women. (9,10) It is the only medication that has unequivocally been shown to reduce the risk of hip fracture in prospective studies. The dosage is 5 to 10 mg/day, taken with a full glass of water at least 30 minutes before the first food, medication, or beverage of the day. Because alendronate can irritate the esophagus, patients should remain upright after taking the drug to avoid possible reflux.

Risedronate (Actonel), in two separate studies involving nearly 2,500 women,11,12 decreased spine fractures by 40% to 50%. However, neither study showed that risedronate reduced hip fractures. In another large study13 evaluating the effect of risedronate on hip fractures in 9,000 women over age 70, about 5,000 women ages 70 to 79 with femoral neck T scores less than 2.5 had no significant reduction in hip fracture risk when taking 2.5 mg/day or 5.0 mg/day. Combining the two dosage groups gave a significant reduction of 39%. Risedronate did not reduce hip frac fractures in 4,000 women over age 80.

References

1. Kanis JA, McCloskey EV. Risk factors in osteoporosis. Maturitas 1998; 30:229-233.

2. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 1999; 282:637-645.

3. Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med 1997; 337:670-676.

4. LeBoff MS, Kohlmeier L, Hurwitz S, Franklin J, Wright J, Glowacki J. Occult vitamin D deficiency in postmenopausal US women with acute hip fracture. JAMA 1999; 281:1505-1511.

5. Cauley JA, Seeley DG, Ensrud K, Ettinger B, Black D, Cummings SR. Estrogen replacement therapy and fractures in older women. Study of Osteoporotic Fractures Research Group. Ann Intern Med 1995; 122:9-16.

6. Kiel DP, Felson DT, Anderson JJ, Wilson PWF, Moskowitz M. Hip fracture and the use of estrogens in postmenopausal women: the Framingham study. N Engl J Med 1987; 317:1169-1174.

7. Lufkin EG, Wahner HW, O'Fallon WM, et al. Treatment of postmenopausal osteoporosis with transdermal estrogen. Ann Intern Med 1992; 117:1-9.

8. Silverman SL, Chesnut C, Andriano K et al for the PROOF Study group. Salmon calcitonin nasal spray (NS-CT) reduces risk of vertebral fracture(s) in established osteoporosis and has continuous efficacy with prolonged treatment: Accrued 5 year worldwide data of the PROOF study [abstract]. Bone 1998; 23(Suppl):S174.

9. Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348:1535-1541.

10. Cummings S, Black D, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. JAMA 1998; 280:2077-2082.

11. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 1999; 282:1344-1352.

12. Reginster J, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporosis International 2000; 11:83-91.

13. Miller P, Roux C, McClung M, et al. Risedronate reduces hip fractures in patients with low femoral neck bone mineral density [abstract]. Arth Rheum 1999; 42(Suppl):S287.

Reprinted from the Cleveland Clinic Journal of Medicine, Volume 67, Number 10, October 2000, Pages 701-703.

Disclosure: Dr. Baran is a consultant with Merck and Procter & Gamble and is a member of the speakers bureaus of Merck, Procter & Gamble, and Wyeth.

Price: $225.00 USD Howard S. An, M.D., Lee H. Riley III, M.D. ISBN: 1-85317-218-9 Howard S An MD: The Morton International Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery, Rush-Presbyterian St Luke's Medical Center, Chicago IL, USA Lee H Riley III MD: Assistant Professor, Department of Orthopaedic Surgery and Neurosurgery, and Director, Orthopaedic Residency Program, Johns Hopkins University School of Medicine, Baltimore MD, USA A definitive, richly illustrated text atlas with comprehensive coverage of positioning, instrumentation, exposures, procedures and techniques, microsurgery and minimally invasive surgery. Patient Positioning and Application of Tongs and Halo Posterior Cervical Spine Procedures Anterior Transoral Procedures Anterior Retropharyngeal Exposures of the Upper Cervical Spine Anterior Exposures of the Lower Cervical Spine and Fusion Techniques Anterior Instrumentations of the Cervical Spine Anterior Exposures of the Cervicothoracic Junction Posterior Exposures of the Thoracic Spine Anterior Exposure and Fusion of the Thoracic Spine Posterior Instrumentation of the Thoracolumbar Spine Lumbar Decompressive Techniques Microsurgery for Lumbar Disc Disease Posterior Lumbar Fusion Procedures Posterior Lumbar Instrumentation Procedures Anterior Exposures and Fusion Techniques of the Lumbar Spine Anterior Thoracolumbar Instrumentations Exposure and Fixation of the Sacrum and Pelvis Malignant Tumors of the Spine and Sacrum Osteotomies Percutaneous Techniques and Minimally Invasive Procedures Intradural Lesions "This atlas will be very useful for surgeons and residents who perform operative procedures on the spine...it will be used frequently." The Journal of Bone and Joint Surgery 1998 Hardcover, 452 pages · 500 Drawings including 150 in Full Colour

Yes, please send me copy(ies) of An Atlas of Surgery of the Spine First Name Last Name Street Address City State/Province Zip/Postal Country Telephone Email Address Visa Mastercard American Express Card Number Expiry Date /