Clinical trial NCT00885170: A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 246
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
timeFrame: Baseline and Month 24
measure: Percentage of Participants Experiencing One or More Adverse Events (AEs)
timeFrame: Up to 25 months
measure: Percentage of Participants Discontinuing Study Drug Due to an AE
timeFrame: Up to 24 months
Secondary outcomes:
measure: Percent Change From Baseline in Femoral Neck BMD at Month 12
timeFrame: Baseline and 12 Months
measure: Percent Change From Baseline in Trochanter BMD at Month 24
timeFrame: Baseline and 24 Months
measure: Percent Change From Baseline in Trochanter BMD at Month 12
timeFrame: Baseline and 12 Months
measure: Percent Change From Baseline in Total Hip BMD at Month 24
timeFrame: Baseline and 24 Months
measure: Percent Change From Baseline in Total Hip BMD at Month 12
timeFrame: Baseline and 12 Months
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 24
timeFrame: Baseline and 24 Months
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 12
timeFrame: Baseline and 12 Months
measure: Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24
timeFrame: Baseline and 24 Months
measure: Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12
timeFrame: Baseline and 12 Months
measure: Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed s-CTx at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12
timeFrame: Baseline and Month 12
measure: Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.