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Treatment of Postmenopausal Osteoporosis with High Doses of Synthetic Calcitriol: A Randomized Controlled Study

J. C. Gallagher, MD; and D. Goldgar, PhD
[+] Article, Author, and Disclosure Information

Grant Support: By a grant from Hoffman La Roche, Nutley, New Jersey.

Requests for Reprints: J.C. Gallagher, MD, Bone Metabolism Unit, Creighton University Medical Center, 601 North 30th Street, Suite 5730, Omaha, NE 68131.

Current Author Addresses: Dr. Gallagher: Creighton University Medical Center, 601 North 30th Street, Suite 5730, Omaha, NE 68131.

Dr. Goldgar: Department of Medical Informatics, University of Utah, Salt Lake City, UT 48108.

© 1990 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1990;113(9):649-655. doi:10.7326/0003-4819-113-9-649
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Objective: To study the efficacy of synthetic 1,25 dihydroxyvitamin D3 (calcitriol) in the treatment of osteoporosis.

Design: Two-year, double-blind, randomized clinical trial.

Setting: University medical center.

Patients: Fifty postmenopausal women with vertebral fractures recruited by referral.

Intervention: Calcium intake was adjusted to 25 mmol/d (1000 mg/d) at baseline. Patients were then randomized to treatment with either calcitriol or placebo. During the study, calcium intake was reduced to 15 mmol/d (600 mg/d) and the dose of calcitriol was adjusted to maintain serum calcium < 2.74 mmol/L (< 11.0 mg/dL) or urine calcium < 9.96 mmol/d (< 400 mg/d).

Measurements and Main Results: After 2 years, the mean dose of calcitriol in the treated group was 0.62 µg/d. Bone mineral density of the spine increased 1.94% with calcitriol therapy and decreased 3.92% with placebo (P = 0.001). Total body calcium increased 0.21% with calcitriol therapy and decreased 1.85% with placebo (P = 0.004). Patients receiving placebo had significant decreases in spine density (P = 0.0007) and total body calcium (P = 0.0004). There were no differences in vertebral fracture rates between the groups. Renal function studies were not statistically different between the groups after 2 years.

Conclusion: The treatment of postmenopausal osteoporotic women with synthetic calcitriol for 2 years was associated with increases in spine density and total body calcium. No adverse effects on renal function were seen after long-term calcitriol therapy.





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