Phase 2
N=156
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00715676 ↗Enrolled (actual)
156
Serious AEs
3.2%
Results posted
Jan 2010
Primary outcome: Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 — -0.537; -0.174; 0.309 Percent change — p=0.641
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); DP001 (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Deltanoid Pharmaceuticals
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 |
-0.537; -0.174; 0.309 | 0.641 |
| SECONDARY Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52 |
-0.315; -0.540; -0.887 | 0.778 |
| SECONDARY Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52 |
-0.428; -1.085; -0.680 | 0.395 |
| SECONDARY Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52 |
-0.375; -0.341; -0.941 | 0.928 |
| SECONDARY Change From Baseline in Serum Calcium Levels at Week 52 |
-0.06; 0.11; 0.29 | — |
| SECONDARY Percent Change From Baseline in Serum Bone Markers at Week 26 |
4.5; 13.8; 54.5; 3.8; 22.4; 80.3 | — |
| SECONDARY Number of Subjects With at Least 1 Treatment-emergent Adverse Event |
41; 45; 46 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal female subjects, defined as amenorrheic for at least 5 years
- Body Mass Index of 18 to 35
- Osteopenic
- Generally healthy
- Informed consent
Exclusion Criteria
- History or evidence of acute or unstable chronic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases
- Current or recent treatment with any medications or products affecting vitamin D metabolism, calcium balance, bone turnover, or an investigational drug therapy
- 12-lead electrocardiogram demonstrating QTc (QT interval corrected for heart rate) >450 milliseconds at screening
- Abnormal creatinine clearance
- Elevated urinary calcium levels
- Vitamin D deficiency
- Excessive dietary calcium or vitamin D intake
- Current use of any illicit drug and/or history of alcohol abuse
Data sourced from ClinicalTrials.gov (NCT00715676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.