Conditions: Osteoporosis
Keywords: Osteoporosis 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3 Vitamin D Bone Density Conservation Agents Bone Regeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 157
Healthy volunteers: no

Brief summary:
This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.

Detailed description:
DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia results in a significant increase in BMD at doses that are safe and well tolerated.

Arms:
arm 1: None arm 2: 220 ng arm 3: 440 ng

Interventions: intervention 1: Placebo intervention 2: DP001
Intervention descriptions: intervention 1: oral, once daily intervention 2: oral, once daily

Protocol document: