OsteoporosisPhase 22MD-3H-2BNCT00715676
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
A Phase 2 study testing DP001 in people with Osteoporosis, run by Deltanoid Pharmaceuticals at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- DP001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal female subjects, defined as amenorrheic for at least 5 years
- Body Mass Index of 18 to 35
- Osteopenic
- Generally healthy
- Informed consent
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106
Bethesda Health Research
Bethesda, Maryland, 20817
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Indiana School of Medicine University Hospital
Indianapolis, Indiana, 46202
University of Wisconsin-Madison Osteoporosis Clinical Research
Madison, Wisconsin, 53705
Winthrop University Hospital Bone Mineral Research Center
Mineola, New York, 11501
Creighton University Bone Metabolism Unit
Omaha, Nebraska, 68131
Boling Clinical Trials
Upland, California, 91786
Helen Hayes Hospital Clinical Research Center
West Haverstraw, New York, 10993
About this study
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
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Placebo, DP001
- Keywords
- Osteoporosis, 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, Vitamin D, Bone Density Conservation Agents, Bone Regeneration
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
oral, once daily
DP001Drug
Also called 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, 2MD
oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| Group 2 | Experimental | 220 ng Receives: Drug: DP001 |
| Group 3 | Experimental | 440 ng Receives: Drug: DP001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
Percent change in lumbar spine BMD (relative to baseline) at Week 52
Measured: Baseline and Week 52
Secondary outcomes (6)
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52
The percent change in hip BMD (relative to baseline) at Week 52
Measured: Baseline and Week 52
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52
Percent change in femoral neck BMD (relative to baseline) at Week 52
Measured: Baseline and Week 52
Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52
Percent change in trochanter BMD (relative to baseline) at Week 52
Measured: Baseline and Week 52
Change From Baseline in Serum Calcium Levels at Week 52
Change in serum calcium value (relative to baseline) at Week 52
Measured: Baseline and Week 52
Percent Change From Baseline in Serum Bone Markers at Week 26
Percent change from baseline at Week 26
Measured: Baseline and Week 26
Number of Subjects With at Least 1 Treatment-emergent Adverse Event
To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deltanoid Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wendy A Bedale, Ph.D., Study director, Deltanoid Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715676
- Sponsor's protocol ID
- Deltanoid 2MD-3H-2B
- Acronym
- 2MD-3H-2B
- Status last verified
- Dec 2009
- First submitted
- 14 Jul 2008
- Last updated
- 11 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 16160732Plum 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.
PubMed 16491322Shevde 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.
PubMed 12374862
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00715676
- Acronym / sponsor ID
- 2MD-3H-2B / Deltanoid 2MD-3H-2B
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, Vitamin D, Bone Density Conservation Agents, Bone Regeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Deltanoid PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Placebo |
| Group 2 | Experimental | Drug: DP001220 ng |
| Group 3 | Experimental | Drug: DP001440 ng |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal female subjects, defined as amenorrheic for at least 5 years
- Body Mass Index of 18 to 35
- Osteopenic
- Generally healthy
- Informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebooral, once daily | Drug | Group 1 |
| DP001Also: 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, 2MDoral, once daily | Drug | Group 2, Group 3 |
Primary outcome
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
Time frame: Baseline and Week 52
Percent change in lumbar spine BMD (relative to baseline) at Week 52
6 secondary outcomes
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Serum Calcium Levels at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Serum Bone Markers at Week 26
Time frame: Baseline and Week 26
Number of Subjects With at Least 1 Treatment-emergent Adverse Event
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16160732Ke 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.
- Background: PubMed 16491322Plum 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.
- Background: PubMed 12374862Shevde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy A Bedale, Ph.D. study director
Deltanoid Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DP001 in people with Osteoporosis, run by Deltanoid Pharmaceuticals at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2010.