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Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620113
First Posted: February 21, 2008
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants.

The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.


Condition Intervention Phase
Osteoporosis Postmenopausal Drug: Odanacatib Dietary Supplement: Vitamin D3 Dietary Supplement: Calcium carbonate Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4) [ Time Frame: Baseline (Observation visit to Wk 0 treatment visit), Week 52 ]
    BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.

  • Number of Participants That Experienced an Adverse Event (AE) [ Time Frame: From first dose up to Post-Study (up to 54 weeks) ]
    An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.

  • Number of Participants That Discontinued Study Drug Due to an AE [ Time Frame: From first dose up to end of treatment (up to 52 weeks) ]
    An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.


Secondary Outcome Measures:
  • Percent Change From Baseline to Week 52 in Total Hip BMD [ Time Frame: Baseline (Observation visit to Wk 0 treatment visit), Week 52 ]
    BMD (g/cm2) data was measured by DXA for total hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.

  • Percent Change From Baseline to Week 52 in Femoral Neck BMD [ Time Frame: Baseline (Observation visit to Wk 0 treatment visit), Week 52 ]
    BMD (g/cm2) data was measured by DXA at the femoral neck subregion of the hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.

  • Percent Change From Baseline to Week 52 in Trochanter BMD [ Time Frame: Baseline (Observation visit to Wk 0 treatment visit), Week 52 ]
    BMD (g/cm2) data was measured by DXA at the trochanter subregion of the hip (near bony protrusions along outside edge of femur) at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.

  • Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio [ Time Frame: Baseline (Wk 0), Week 52 ]
    The u-NTx/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-NTx/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.

  • Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level [ Time Frame: Baseline (Wk 0), Week 52 ]
    s-CTx is a biochemical marker index of bone resorption. Blood samples were collected in the morning and in fasting state for measurement of s-CTx. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.

  • Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre) [ Time Frame: Baseline (Wk 0), Week 52 ]
    The u-DPD/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-DPD/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.

  • Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level [ Time Frame: Baseline (Wk 0), Week 52 ]
    s-BSAP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s-BSAP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.

  • Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level [ Time Frame: Baseline (Wk 0), Week 52 ]
    s-P1NP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s- P1NP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.


Enrollment: 287
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Dietary Supplement: Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Other Name: cholecalciferol
Dietary Supplement: Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Drug: Placebo
Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
Experimental: Odanacatib 10 mg
After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Drug: Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Other Name: MK-0822
Dietary Supplement: Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Other Name: cholecalciferol
Dietary Supplement: Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Experimental: Odanacatib 25 mg
After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Drug: Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Other Name: MK-0822
Dietary Supplement: Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Other Name: cholecalciferol
Dietary Supplement: Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Placebo Comparator: Odanacatib 50 mg
After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Drug: Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Other Name: MK-0822
Dietary Supplement: Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Other Name: cholecalciferol
Dietary Supplement: Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
  • Participant who has low bone mineral density
  • Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
  • Participant is ambulatory (can walk)

Exclusion Criteria:

  • Participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
  • Participant has received osteoporosis medications or other medications that affect bone
  • Participant is already participating in another drug study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620113


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00620113     History of Changes
Other Study ID Numbers: 0822-022
MK-0822-022 ( Other Identifier: Merck Registration Number )
2007_034 ( Other Identifier: Merck )
First Submitted: January 29, 2008
First Posted: February 21, 2008
Results First Submitted: January 23, 2017
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents