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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00885170
First received: April 20, 2009
Last updated: March 6, 2017
Last verified: March 2017
April 20, 2009
March 6, 2017
April 2009
September 2011   (Final data collection date for primary outcome measure)
  • 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.
Percent change in BMD from baseline at the femoral neck site assessed by DXA [ Time Frame: 24 Months ]
Complete list of historical versions of study NCT00885170 on ClinicalTrials.gov Archive Site
  • 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.
  • Percent change in BMD from baseline at the trochanter, total hip, lumbar spine, total body and forearm sites assessed by DXA [ Time Frame: 24 Months ]
  • Evaluate the effect of treatment on biochemical markers of bone turnover and indices of calcium and mineral homeostasis [ Time Frame: 24 months ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Osteoporosis
  • Drug: Odanacatib
    Odanacatib 50 mg tablets once weekly for 24 months
  • 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.
  • 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.
    Interventions:
    • Drug: Odanacatib
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Calcium
  • 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.
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Calcium
Bonnick S, De Villiers T, Odio A, Palacios S, Chapurlat R, DaSilva C, Scott BB, Le Bailly De Tilleghem C, Leung AT, Gurner D. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Czech Republic,   France,   Germany,   India,   Jordan,   Norway,   Poland,   South Africa,   Spain,   Taiwan,   United States
 
NCT00885170
0822-042
2009_578 ( Other Identifier: Merck Registration Number )
CTRI/2009/091/000218 ( Registry Identifier: CTRI )
2008-008257-30 ( EudraCT Number )
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP