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Study halted prematurely due to low enrollment.
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The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odanacatib 50 mg | Experimental | Participants will receive odanacatib 50 mg once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 international units (IU) of Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
|
| Placebo | Placebo Comparator | Participants will receive dose-matched placebo to odanacatib once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 IU Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| odanacatib | Drug | odanacatib 50 mg oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Month 12 in Femoral BMD | Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib | DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24. | Baseline and Month 24 |
| Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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The Sponsor made a business decision to terminate the trial early due to poor enrollment; the decision was not related to any findings regarding the efficacy or safety profile of odanacatib.
Postmenopausal female participants ≥60 years of age with low bone mineral density (BMD) and who had been treated with an oral bisphosphonate for at least 3 years were recruited at 81 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Odanacatib 50 mg | Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
| FG001 | Placebo | Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Odanacatib 50 mg | Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 to Month 12 in Femoral BMD | Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12. | The Full Analysis set (FAS) includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements. | Posted | Mean | Standard Error | Percent Change from Baseline | Baseline and Month 12 |
|
Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
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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 | ODN 50 mg OW | Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C527128 | odanacatib |
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| placebo to odanacatib | Other | dose-matched placebo to odanacatib, oral tablet |
|
DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12. |
| Baseline and Month 12 |
| Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx) | s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline. | Baseline and Month 12 |
| Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx) | u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline. | Baseline and Month 12 |
| Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr) | The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline. | Baseline and Month 12 |
| Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP) | s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline. | Baseline and Month 12 |
| Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP) | s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline. | Baseline and Month 12 |
| Protocol Violation |
|
| Study terminated by sponsor |
|
| Withdrawal by Subject |
|
| BG001 |
| Placebo |
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
|
|
| Secondary | Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib | DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24. | The trial was terminated prematurely, thus this analysis was not conducted. | Posted | Baseline and Month 24 |
|
|
| Secondary | Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD | DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12. | The FAS includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements | Posted | Mean | Standard Error | Percentage Change from Baseline | Baseline and Month 12 |
|
|
|
| Secondary | Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx) | s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline. | The Per Protocol (PP) population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results. | Posted | Geometric Mean | Standard Error | Percent Change from Baseline | Baseline and Month 12 |
|
|
|
| Secondary | Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx) | u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline. | The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results. | Posted | Geometric Mean | Standard Error | Percentage Change from Baseline | Baseline and Month 12 |
|
|
|
| Secondary | Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr) | The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline. | The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results. | Posted | Geometric Mean | Standard Error | Percentage Change from Baseline | Baseline and Month 12 |
|
|
|
| Secondary | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP) | s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline. | The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results | Posted | Geometric Mean | Standard Error | Percentage Change from Baseline | Baseline and Month 12 |
|
|
|
| Secondary | Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP) | s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline. | The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results | Posted | Geometric Mean | Standard Error | Percentage Change from Baseline | Baseline and Month 12 |
|
|
|
| 6 |
| 67 |
| 15 |
| 67 |
| EG001 | Placebo OW | Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses. | 4 | 68 | 9 | 68 |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| D009750 |
| Nutritional and Metabolic Diseases |
| Lumbar Spine |
|