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Response to teriparatide in patients with baseline 25-hydroxyvitamin D insufficiency or sufficiency.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2007 Dec; Vol. 92 (12), pp. 4630-6. Date of Electronic Publication: 2007 Oct 02. - Publication Year :
- 2007
-
Abstract
- Context: Serum 25-hydroxyvitamin D (25OHD) concentrations greater than 30 ng/ml have been recommended for lowering fracture risk.<br />Objective: Our objective was to determine whether 25OHD sufficiency is a prerequisite for effective response to teriparatide (TPTD).<br />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 <or=30 ng/ml) or 25OHD sufficiency (>30 but <or=183 ng/ml) at the baseline (randomization) visit. An abnormal intact PTH was exclusionary.<br />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 microg TPTD by daily sc injection for a median of 19 months. Observation was for a median of 21 months.<br />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.<br />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.<br />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.
- Subjects :
- Aged
Biomarkers metabolism
Bone Density
Bone Development drug effects
Calcium blood
Collagen Type I blood
Double-Blind Method
Female
Fractures, Bone diagnostic imaging
Fractures, Bone epidemiology
Fractures, Bone prevention & control
Humans
Middle Aged
Nutritional Status
Radiography
Risk Reduction Behavior
Spinal Fractures epidemiology
25-Hydroxyvitamin D 2 blood
Bone Density Conservation Agents pharmacology
Calcifediol blood
Osteoporosis, Postmenopausal prevention & control
Teriparatide pharmacology
Vitamin D Deficiency blood
Vitamin D Deficiency drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0021-972X
- Volume :
- 92
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 17911178
- Full Text :
- https://doi.org/10.1210/jc.2007-0239