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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator |
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| Group 2 | Experimental | 220 ng |
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| Group 3 | Experimental | 440 ng |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | oral, once daily |
| |
| DP001 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 52 |
| Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Wendy A Bedale, Ph.D. | Deltanoid Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boling Clinical Trials | Upland | California | 91786 | United States | ||
| Indiana School of Medicine University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16160732 | Background | 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. | |
| 16491322 |
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Subjects were enrolled from 5 March 2007 to 19 December 2007 at 9 centers within the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo soft gel capsules, oral, once daily |
| FG001 | 220 ng of Vitamin D Analog (DP001) | 220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
oral, once daily |
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Percent change in femoral neck BMD (relative to baseline) at Week 52
| 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 | 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 | Baseline and Week 52 |
| Percent Change From Baseline in Serum Bone Markers at Week 26 | Percent change from baseline at Week 26 | 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. | 1 year |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Bethesda Health Research | Bethesda | Maryland | 20817 | United States |
| Creighton University Bone Metabolism Unit | Omaha | Nebraska | 68131 | United States |
| New Mexico Clinical Research and Osteoporosis Center | Albuquerque | New Mexico | 87106 | United States |
| Winthrop University Hospital Bone Mineral Research Center | Mineola | New York | 11501 | United States |
| Helen Hayes Hospital Clinical Research Center | West Haverstraw | New York | 10993 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| University of Wisconsin-Madison Osteoporosis Clinical Research | Madison | Wisconsin | 53705 | United States |
| 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. |
| 12374862 | Background | 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. |
| FG002 | 440 ng DP001 | 440 ng DP001 soft gel capsules, oral, once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo soft gel capsules, oral, once daily |
| BG001 | 220 ng DP001 | 220 ng DP001 soft gel capsules, oral, once daily |
| BG002 | 440 ng DP001 | 440 ng DP001 soft gel capsules, oral, once daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 52 |
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| Secondary | 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 | This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 52 |
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| Secondary | 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 | This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 52 |
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| Secondary | Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52 | Percent change in trochanter BMD (relative to baseline) at Week 52 | This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 52 |
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| Secondary | Change From Baseline in Serum Calcium Levels at Week 52 | Change in serum calcium value (relative to baseline) at Week 52 | This analysis was done for all subjects for whom both baseline and Week 52 data was available. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52 |
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| Secondary | Percent Change From Baseline in Serum Bone Markers at Week 26 | Percent change from baseline at Week 26 | Analyses were performed using subjects for whom both Baseline and Week 26 samples were available. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 26 |
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| Secondary | 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. | The participants for this analysis included all randomized subjects who received a dose of study drug. | Posted | Number | Participants | 1 year |
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Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo soft gel capsules, oral, once daily | 1 | 49 | 38 | 49 | ||
| EG001 | 220 ng DP001 | 220 ng DP001 soft gel capsules, oral, once daily | 1 | 54 | 37 | 54 | ||
| EG002 | 440 ng DP001 | 440 ng DP001 soft gel capsules, oral, once daily | 3 | 53 | 44 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
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| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
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| Hypercalciuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (9.0) | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hector F. DeLuca, President and Chief Executive Officer | Deltanoid Pharmaceuticals | 608-238-7710 | info@deltanoid.com |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance |
| ANOVA |
| 0.243 |
The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate. |
| 95 |
| No |
| Superiority or Other |
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