Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatments mk0822, vitamin d3, calcium carbonate, placebo
Phase phase 2
Sponsor Merck Sharp & Dohme Corp.
Start date June 2005
End date December 2007
Trial size 399 participants
Trial identifier NCT00112437, 0822-004, 2005_023

Summary

This is a 2-year study to examine the effects of a new experimental medication (MK0822) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of MK0822or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
vitamin d3
Vitamin D3, two 2800 IU weekly throughout the study
calcium carbonate
Patient who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
placebo
Placebo to MK0822 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months
(Experimental)
mk0822
MK0822 3 mg, once weekly for 24 months
vitamin d3
Vitamin D3, two 2800 IU weekly throughout the study
calcium carbonate
Patient who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
(Experimental)
mk0822
MK0822 10 mg, once weekly for 24 months
vitamin d3
Vitamin D3, two 2800 IU weekly throughout the study
calcium carbonate
Patient who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
(Experimental)
mk0822
MK0822 25 mg, once weekly for 24 months
vitamin d3
Vitamin D3, two 2800 IU weekly throughout the study
calcium carbonate
Patient who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
(Experimental)
mk0822
MK0822 50 mg, once weekly for 24 months
vitamin d3
Vitamin D3, two 2800 IU weekly throughout the study
calcium carbonate
Patient who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.

Primary Outcomes

Measure
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 12 Months
time frame: Baseline and 12 months
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 24 Months
time frame: Baseline and 24 months
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 36 Months
time frame: Baseline and 36 months

Secondary Outcomes

Measure
Percentage Change in Total Hip Bone Mineral Density at 12 Months
time frame: Baseline and 12 months
Percentage Change in Femoral Neck Bone Mineral Density at 12 Months
time frame: Baseline and 12 months
Percentage Change in Trochanter Bone Mineral Density at 12 Months
time frame: Baseline and 12 Months
Percentage Change in Total Body Bone Mineral Density at 12 Months
time frame: Baseline and 12 Months
Percentage Change in Distal Forearm Bone Mineral Density at 12 Months
time frame: Baseline and 12 Months
Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 12 Months
time frame: Baseline and 12 Months
Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 12 Months
time frame: Baseline and 12 Months
Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 12 Months
time frame: Baseline and 12 months
Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 12 Months
time frame: Baseline and 12 months
Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 12 Months
time frame: Baseline and 12 months
Percentage Change in Total Hip Bone Mineral Density at 24 Months
time frame: Baseline and 24 months
Percentage Change in Femoral Neck Bone Mineral Density at 24 Months
time frame: Baseline and 24 months
Percentage Change in Tronchanter Bone Mineral Density at 24 Months
time frame: Baseline and 24 months
Percentage Change in Total Body Bone Mineral Density at 24 Months
time frame: Baseline and 24 months
Percentage Change in Distal Forearm Bone Mineral Density at 24 Months
time frame: Baseline and 24 months
Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 24 Months
time frame: Baseline and 24 months
Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 24 Months
time frame: Baseline and 24 months
Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 24 Months
time frame: Baseline and 24 months
Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months
time frame: Baseline and 24 months
Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 24 Months
time frame: Baseline and 24 months
Percentage Change From Baseline in Total Hip Bone Mineral Density at 36 Months
time frame: Baseline and 36 months
Percentage Change From Baseline in Femoral Neck Bone Mineral Density at 36 Months
time frame: Baseline and 36 months
Percentage Change From Baseline in Trochanter Bone Mineral Density at 36 Months
time frame: Baseline and 36 months
Percentage Change From Baseline in Total Body Bone Mineral Density at 36 Months
time frame: Baseline and 36 months
Percentage Change From Baseline in Distal Forearm Bone Mineral Density at 36 Months
time frame: Baseline and 36 months
Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen [u-NTx]) at 36 Months
time frame: Baseline and 36 months
Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
time frame: Baseline and 36 months
Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
time frame: Baseline and 36 months
Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
time frame: Baseline and 36 months
Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
time frame: Baseline and 36 months
Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b) [TRAP 5-b]) at 36 Months
time frame: Baseline and 36 months
Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
time frame: Baseline and 36 months

Eligibility Criteria

Female participants from 45 years up to 85 years old.

Inclusion Criteria: - Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy - Bone mineral density T-score at the hip or spine of -2.0 or less - Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.) - At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures) - In a state of general health allowing for successful completion of the trial - Agreement to not use any medications to treat osteoporosis during the study Exclusion Criteria: - History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy) - Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details) - Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason)

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK0822 in the Treatment of Postmenopausal Women With Osteoporosis
Description Study Extension: Participants who completed 24 months of the base study were invited to continue in three extensions: MK0822-004-10, which extended the study to 36 months, MK0822-004-20 (NCT00112437) which extended the study to 60 months, and MK0822-004-30 (NCT00112437), which extended the study to 120 months. - In the first extension, participants were re-randomized to 50 mg MK0822 or placebo OW for 12 months. - In the second extension, participants who were initially randomized to MK0822 3 mg or placebo OW in the base study received MK0822 50 mg weekly in Years 4&5; all other participants remained on the same treatment they were during Year 3. - In the third extension, all participants received odanacatib weekly in Years 6-10. Study arms for extensions include only 50 mg MK0822 and placebo for the first two extensions and 50 mg MK0822 only for the third extension. Extension Studies: MK0822-004-10 (NCT00112437) Extension: Patient has participated in and completed 24 months of treatment in the base study MK0822-004-20 (NCT00112437) Extension: Patient participated in and completed 36 months of treatment in base and extension studies. MK0822-004-30 (NCT00112437) Extension: Patient participated in and completed 60 months of treatment in the base and extension studies.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..