Skip to main content
ARS Home » Northeast Area » Boston, Massachusetts » Jean Mayer Human Nutrition Research Center On Aging » Research » Publications at this Location » Publication #209413
Title: Response to Teriparatide in Patients with Baseline 25-Hydroxyvitamin D Insufficiency or Sufficiency

Author
item Dawson-Hughes, Bess
item CHEN, PEIGI - LILLY RESEARCH LAB, IN
item KREGE, JOHN - LILLY RESEARCH LAB, IN

Submitted to: Journal of Clinical Endocrinology and Metabolism
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 9/25/2007
Publication Date: 12/1/2007
Citation: Dawson-Hughes, B., Chen, P., Krege, J.H. 2007. Response to Teriparatide in Patients with Baseline 25-Hydroxyvitamin D Insufficiency or Sufficiency. Journal of Clinical Endocrinology and Metabolism. 92(12):4630-6.

Interpretive Summary: Vitamin D insufficiency is known to increase risk of fracture. In patients being considered for pharmacotherapy for osteoporosis, it is unclear whether vitamin D insufficiency needs to be corrected before starting pharmacotherapy or whether concurrent treatment with vitamin D and pharmacotherapy is satisfactory. In this study the effects of treatment with the anabolic agent, teriparatide, on bone mineral density and fracture risk were compared in 1620 osteoporotic postmenopausal women with low-normal or high-normal vitamin D levels. Treatment with teriparatide lowered risk of fracture and increased bone mineral density similarly in the two groups. Thus in osteoporotic patients with low-normal vitamin D levels, it is not necessary to withhold treatment with teriparatide for several months while vitamin D insufficiency is being corrected.

Technical Abstract: Serum 25-hydroxyvitamin D (25OHD) concentrations >30 ng/ml have been recommended for lowering fracture risk. The objective of this study was to determine if 25OHD sufficiency is a prerequisite for effective response to teriparatide (TPTD). Study data came from 1620 osteoporotic postmenopausal women in the Fracture Prevention Trial. The response to teriparatide was assessed in women subgrouped by having 25OHD insufficiency (greater than10 but less than or equal to 30 ng/ml) or 25OHD sufficiency ( greater than 30 but less than or equal to183 ng/ml) at the baseline (randomization) visit. An abnormal intact PTH was exclusionary. At baseline, after at least 1 month of supplementation with calcium (1000 mg) and vitamin D (400 to 1200 IU) daily, women were randomized to placebo, TPTD 20 ug or TPTD 40 ug by daily subcutaneous injection for a median of 19 months. Observation was for a median of 21 months. The main outcome measures were vertebral and nonvertebral fractures, change in bone mineral density (BMD) at the lumbar spine and femoral neck, change in bone formation marker amino-terminal extension peptide of procollagen type 1 (PINP), and the proportion of women with serum calcium greater than or equal to 2.76 mmol/L 4 to 6 hours after dosing. The results showed that TPTD reduced vertebral and nonvertebral fracture risk, increased lumbar spine and femoral neck BMD, and increased PINP relative to placebo in the two 25OHD subgroups. The changes in these endpoints were statistically consistent among women with baseline 25OHD sufficiency and insufficiency. We can conclude, therefore, that in postmenopausal women with osteoporosis and normal intact PTH, the response to TPTD was similar in women with baseline 25OHD insufficiency or sufficiency.