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A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885170
First Posted: April 21, 2009
Last Update Posted: April 18, 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 study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 [ Time Frame: Baseline and Month 24 ]
    BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.

  • Percentage of Participants Experiencing One or More Adverse Events (AEs) [ Time Frame: Up to 25 months ]
    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

  • Percentage of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to 24 months ]
    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.


Secondary Outcome Measures:
  • Percent Change From Baseline in Femoral Neck BMD at Month 12 [ Time Frame: Baseline and 12 Months ]
    BMD at the femoral neck was assessed by DXA at baseline and Month 12.

  • Percent Change From Baseline in Trochanter BMD at Month 24 [ Time Frame: Baseline and 24 Months ]
    BMD at the trochanter was assessed by DXA at baseline and Month 24.

  • Percent Change From Baseline in Trochanter BMD at Month 12 [ Time Frame: Baseline and 12 Months ]
    BMD at the trochanter was assessed by DXA at baseline and Month 12.

  • Percent Change From Baseline in Total Hip BMD at Month 24 [ Time Frame: Baseline and 24 Months ]
    BMD at the total hip was assessed by DXA at baseline and Month 24.

  • Percent Change From Baseline in Total Hip BMD at Month 12 [ Time Frame: Baseline and 12 Months ]
    BMD at the total hip was assessed by DXA at baseline and Month 12.

  • Percent Change From Baseline in Lumbar Spine BMD at Month 24 [ Time Frame: Baseline and 24 Months ]
    BMD at the lumbar spine was assessed by DXA at baseline and Month 24.

  • Percent Change From Baseline in Lumbar Spine BMD at Month 12 [ Time Frame: Baseline and 12 Months ]
    BMD at the lumbar spine was assessed by DXA at baseline and Month 12.

  • Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24 [ Time Frame: Baseline and 24 Months ]
    BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.

  • Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12 [ Time Frame: Baseline and 12 Months ]
    BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.

  • Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24 [ Time Frame: Baseline and Month 24 ]
    s-CTx is a biochemical marker of bone resorption.

  • Percent Change From Baseline in Log-Transformed s-CTx at Month 12 [ Time Frame: Baseline and Month 12 ]
    s-CTx is a biochemical marker of bone resorption.

  • Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24 [ Time Frame: Baseline and Month 24 ]
    N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.

  • Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12 [ Time Frame: Baseline and Month 12 ]
    u-NTx/Cr is a biochemical marker of bone resorption.

  • Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24 [ Time Frame: Baseline and Month 24 ]
    Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.

  • Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12 [ Time Frame: Baseline and Month 12 ]
    BSAP is a biochemical marker of bone formation.

  • Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.

  • Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12 [ Time Frame: Baseline and Month 12 ]
    s-P1NP is a biochemical marker of bone formation.

  • Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum calcium is an index of calcium homeostasis.

  • Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum phosphate is an index of mineral homeostasis.

  • Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.

  • Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24 [ Time Frame: Baseline and Month 24 ]
    1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.

  • Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24 [ Time Frame: Baseline and Month 24 ]
    The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.


Enrollment: 246
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Odanacatib 50 mg
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Drug: Odanacatib
Odanacatib 50 mg tablets once weekly for 24 months
Dietary Supplement: Vitamin D3
Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
Dietary Supplement: Calcium
Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Placebo Comparator: Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Drug: Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months
Dietary Supplement: Vitamin D3
Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
Dietary Supplement: Calcium
Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

  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:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has been postmenopausal for at least 5 years
  • Has taken or is taking alendronate
  • Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria:

  • Has a history or evidence of hip fracture
  • Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
  • Has active parathyroid disease
  • Has a history of thyroid disease not adequately controlled by medication
  • Is taking anti-seizure medication and has abnormal calcium metabolism
  • Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
  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): NCT00885170


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00885170     History of Changes
Other Study ID Numbers: 0822-042
2009_578 ( Other Identifier: Merck Registration Number )
CTRI/2009/091/000218 ( Registry Identifier: CTRI )
2008-008257-30 ( EudraCT Number )
First Submitted: April 20, 2009
First Posted: April 21, 2009
Results First Submitted: January 3, 2017
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal 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