A Phase 3 interventional study of Odanacatib and Placebo for Odanacatib in Osteoporosis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-08-28.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 294 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
Drug: Odanacatib · Dietary Supplement: Vitamin D3 · Dietary Supplement: Calcium carbonate
Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
Drug: Placebo for Odanacatib · Dietary Supplement: Vitamin D3 · Dietary Supplement: Calcium carbonate
One 50 mg tablet once weekly
Also known as: MK-0822
One 50 mg tablet once weekly
5600 IU of open-label Vitamin D3 once weekly
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Time frame: Baseline and Month 24
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Time frame: Up to 24 months (plus 14 days) after first dose of study drug
Number of Participants Who Discontinued Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Time frame: Up to 24 months after first dose of study drug
Percentage Change From Baseline in Total Hip BMD at Month 24
Total hip BMD was assessed by DXA at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Femoral Neck BMD at Month 24
Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Trochanter BMD at Month 24
Trochanter BMD was assessed by DXA at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
| Milestone | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Started | 147 | 147 |
| Treated | 146 | 146 |
| Completed | 128 | 115 |
| Not completed | 19 | 32 |
| Withdrew: Adverse event | 7 | 7 |
| Withdrew: Excessive bone loss | 0 | 4 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Physician decision | 1 | 3 |
| Withdrew: Protocol violation | 0 | 4 |
| Withdrew: Withdrawal by subject | 10 | 11 |
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 | 6.86 (6.08 to 7.64) | 1.27 (0.48 to 2.06) |
Total hip BMD was assessed by DXA at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Total Hip BMD at Month 24 | 1.91 (1.38 to 2.43) | -0.11 (-0.65 to 0.42) |
Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Femoral Neck BMD at Month 24 | 1.69 (0.82 to 2.55) | 0 (-0.89 to 0.88) |
Trochanter BMD was assessed by DXA at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Trochanter BMD at Month 24 | 2.77 (1.94 to 3.6) | 0.66 (-0.18 to 1.5) |
Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24 | -20.07 (-28.36 to -10.82) | 56.51 (40.01 to 74.96) |
Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24 | -61.43 (-64.71 to -57.85) | 6.65 (-2.68 to 16.87) |
Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24 | -5.28 (-9.76 to -0.57) | 2.66 (-2.25 to 7.82) |
Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.
| Percentage change | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24 | -10.94 (-17.27 to -4.14) | 5.06 (-2.47 to 13.17) |
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
| Participants | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 113 | 114 |
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
| Participants | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Number of Participants Who Discontinued Treatment Due to an AE | 5 | 6 |
Collected over Up to 24 months (plus 14 days) after first dose of study drug. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Odanacatib 50 mg Once Weekly | — | 24/146 (16.4%) | 30/146 (20.5%) |
| Placebo Once Weekly | — | 24/146 (16.4%) | 44/146 (30.1%) |
| Event | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| Myocardial infarctionCardiac disorders | 0/146 | 2/146 |
| Clavicle fractureInjury, poisoning and procedural complications | 2/146 | 1/146 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 2/146 | 0/146 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/146 | 2/146 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 2/146 | 0/146 |
| Angina pectorisCardiac disorders | 0/146 | 1/146 |
| Angina unstableCardiac disorders | 1/146 | 0/146 |
| Atrioventricular block second degreeCardiac disorders | 1/146 | 0/146 |
| Cardiac failure congestiveCardiac disorders | 1/146 | 0/146 |
| Coronary artery stenosisCardiac disorders | 1/146 | 0/146 |
| Event | Odanacatib 50 mg Once Weekly | Placebo Once Weekly |
|---|---|---|
| NasopharyngitisInfections and infestations | 14/146 | 15/146 |
| Back painMusculoskeletal and connective tissue disorders | 9/146 | 12/146 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/146 | 10/146 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/146 | 10/146 |
| Influenza like illnessGeneral disorders | 4/146 | 9/146 |
| Age, Continuous(years) | Odanacatib 50 mg Once Weekly | Placebo Once Weekly | Total |
|---|---|---|---|
| Mean | 68.9 ± 8.2 | 68.7 ± 7.7 | 68.8 ± 7.9 |
| Sex: Female, Male(Participants) | Odanacatib 50 mg Once Weekly | Placebo Once Weekly | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 147 | 147 | 294 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC