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Response to Teriparatide in Patients with Baseline 25-Hydroxyvitamin D Insufficiency or Sufficiency

Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging (B.D.-H.), Tufts University, Boston, Massachusetts 02111; and Lilly Research Laboratories (P.C., J.H.K.), Eli Lilly and Company, Indianapolis, Indiana 46285

Address all correspondence and requests for reprints to: Bess Dawson-Hughes, M.D., Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, 711 Washington Street, Boston, Massachusetts 02111-1524. E-mail: bess.dawson-hughes{at}tufts.edu.

Context: Serum 25-hydroxyvitamin D (25OHD) concentrations greater than 30 ng/ml have been recommended for lowering fracture risk.

Objective: Our objective was to determine whether 25OHD sufficiency is a prerequisite for effective response to teriparatide (TPTD).

Design and Patients: Data were from 1620 osteoporotic postmenopausal women in the Fracture Prevention Trial. The response to TPTD was assessed in women subgrouped by having 25OHD insufficiency (>10 but 30 ng/ml) or 25OHD sufficiency (>30 but 183 ng/ml) at the baseline (randomization) visit. An abnormal intact PTH was exclusionary.

Interventions: At baseline, after at least 1 month of supplementation with calcium (1000 mg) and vitamin D (400–1200 IU) daily, women were randomized to placebo or 20 or 40 µg TPTD by daily sc injection for a median of 19 months. Observation was for a median of 21 months.

Main Outcome Measures: Main outcome measures included vertebral and nonvertebral fractures, change in bone mineral density at the lumbar spine and femoral neck, change in bone formation marker amino-terminal extension peptide of procollagen type 1, and the proportion of women with serum calcium at least 2.76 mmol/liter 4–6 h after dosing.

Results: TPTD reduced vertebral and nonvertebral fracture risk, increased lumbar spine and femoral neck bone mineral density, and increased amino-terminal extension peptide of procollagen type 1 relative to placebo in the two 25OHD subgroups. There were no significant differences in these endpoints between the subgroups (each treatment by subgroup interaction, P > 0.10). However, it should be noted that because of the limited number of fractures, this study does not exclude the possibility of differences in fracture outcome between the subgroups.

Conclusions: In postmenopausal women with osteoporosis and normal intact PTH, the responses to TPTD did not differ significantly in women with baseline 25OHD insufficiency or sufficiency.