Clinical trial NCT00715676: Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
Official title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Daily-dose, Proof-of-concept Study of a Vitamin D Compound in Postmenopausal Women With Osteopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: Osteoporosis
2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
Vitamin D
Bone Density Conservation Agents
Bone Regeneration
Lead sponsor: Deltanoid Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 157
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52
timeFrame: Baseline and Week 52
measure: Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52
timeFrame: Baseline and Week 52
measure: Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Serum Calcium Levels at Week 52
timeFrame: Baseline and Week 52
measure: Percent Change From Baseline in Serum Bone Markers at Week 26
timeFrame: Baseline and Week 26
measure: Number of Subjects With at Least 1 Treatment-emergent Adverse Event
timeFrame: 1 year
Other outcomes:
Locations:
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Indianapolis
country: United States
facility: Indiana School of Medicine University Hospital
state: Indiana
city: Bethesda
country: United States
facility: Bethesda Health Research
state: Maryland
city: Omaha
country: United States
facility: Creighton University Bone Metabolism Unit
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center
state: New Mexico
city: Mineola
country: United States
facility: Winthrop University Hospital Bone Mineral Research Center
state: New York
city: West Haverstraw
country: United States
facility: Helen Hayes Hospital Clinical Research Center
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin-Madison Osteoporosis Clinical Research
state: Wisconsin
Study officials:
affiliation: Deltanoid Pharmaceuticals
name: Wendy A Bedale, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Ke HZ, Qi H, Crawford DT, Simmons HA, Xu G, Li M, Plum L, Clagett-Dame M, DeLuca HF, Thompson DD, Brown TA. A new vitamin D analog, 2MD, restores trabecular and cortical bone mass and strength in ovariectomized rats with established osteopenia. J Bone Miner Res. 2005 Oct;20(10):1742-55. doi: 10.1359/JBMR.050605. Epub 2005 Jun 13.
citation: Plum LA, Fitzpatrick LA, Ma X, Binkley NC, Zella JB, Clagett-Dame M, DeLuca HF. 2MD, a new anabolic agent for osteoporosis treatment. Osteoporos Int. 2006;17(5):704-15. doi: 10.1007/s00198-005-0036-3. Epub 2006 Feb 21.
citation: Shevde NK, Plum LA, Clagett-Dame M, Yamamoto H, Pike JW, DeLuca HF. A potent analog of 1alpha,25-dihydroxyvitamin D3 selectively induces bone formation. Proc Natl Acad Sci U S A. 2002 Oct 15;99(21):13487-91. doi: 10.1073/pnas.202471299. Epub 2002 Oct 8.