Phase 2
N=399
A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00112437 ↗Enrolled (actual)
399
Serious AEs
16.3%
Results posted
May 2010
Primary outcome: Primary: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months — -0.13; -0.62; 1.50; 2.65 Percentage change — p=<=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Odanacatib (Drug); Vitamin D3 (Dietary_supplement); Calcium Carbonate (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months |
-0.13; -0.62; 1.50; 2.65; 3.37 | <=0.001 sig |
| PRIMARY Percentage Change From Baseline in Lumbar Spine BMD at 24 Months |
-0.19; -1.03; 3.20; 4.26; 5.48 | <=0.001 sig |
| PRIMARY Percentage Change From Baseline in Lumbar Spine BMD at 36 Months |
0.42; 2.95; -1.57; 4.41; 2.03; 6.11 | — |
| PRIMARY Percentage Change From Baseline in Lumbar Spine BMD at 60 Months |
-0.41; 11.88 | — |
| PRIMARY Percentage Change From Baseline in Lumbar Spine BMD at 120 Months |
16.92; 14.56; 17.18; 7.71 | — |
| PRIMARY Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months) |
27; 34; 23; 32 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months) |
1; 2; 0; 1 | — |
| SECONDARY Percentage Change From Baseline in Total Hip BMD at 12 Months |
-0.61; -1.36; 1.05; 1.45; 1.87 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Femoral Neck BMD at 12 Months |
-0.13; -0.32; 0.74; 1.76; 2.53 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Trochanter BMD at 12 Months |
-0.73; -1.02; 1.65; 1.91; 2.21 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Total Body BMD at 12 Months |
-0.42; -1.89; -1.06; -0.51; -0.13 | 0.112 |
| SECONDARY Percentage Change From Baseline in Distal Forearm BMD at 12 Months |
-1.27; -2.55; -1.00; -0.17; -0.04 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months |
-2.37; 8.80; -34.21; -48.29; -60.23 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months |
-0.58; 19.12; -22.24; -36.15; -56.91 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months |
-7.25; 20.91; -8.58; -8.50; -25.52 | 0.004 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months |
-2.77; 42.08; 8.95; 2.66; -18.35 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months |
3.91; 50.81; 2.33; 2.23; -31.83 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months |
-0.93; -1.44; 1.82; 2.55; 3.16 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Femoral Neck BMD at 24 Months |
-0.85; -1.25; 1.97; 2.73; 3.84 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Trochanter BMD at 24 Months |
-0.81; -0.85; 3.61; 3.75; 4.28 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Total Body BMD at 24 Months |
-1.54; -2.70; -1.35; -0.43; 0.19 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Distal Forearm BMD at 24 Months |
-2.75; -5.70; -1.22; -0.65; 0.15 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months |
-4.62; 12.89; -40.57; -38.30; -51.83 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months |
32.77; 54.94; 8.79; -6.52; -30.57 | <=0.001 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months |
-5.78; 15.96; -7.57; -14.30; -22.49 | 0.015 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months |
3.38; 40.17; 2.99; 10.62; -13.62 | 0.002 sig |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months |
1.29; 50.52; 9.07; 14.60; -20.20 | 0.011 sig |
| SECONDARY Percentage Change From Baseline in Total Hip BMD at 36 Months |
-0.77; 1.16; -0.63; 2.75; 0.96; 4.61 | — |
| SECONDARY Percentage Change From Baseline in Femoral Neck BMD at 36 Months |
-0.52; 1.03; -1.04; 2.26; -0.14; 5.06 | — |
| SECONDARY Percentage Change From Baseline in Trochanter BMD at 36 Months |
-0.46; 2.32; -1.04; 4.53; 0.66; 8.21 | — |
| SECONDARY Percentage Change From Baseline in Total Body BMD at 36 Months |
0.13; -2.20; -3.63; 0.28; -2.28; -1.22 | — |
| SECONDARY Percentage Change From Baseline in Distal Forearm BMD at 36 Months |
-2.08; -4.04; -6.59; -6.34; -1.74; -3.74 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months |
-17.43; -55.12; -11.90; -57.17; -12.15; -49.10 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months |
-0.09; -41.30; -4.69; -44.62; 18.24; -26.26 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months |
-18.69; -14.95; -7.82; -26.27; -4.69; 0.43 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months |
7.73; 10.86; 14.26; 9.13; 12.95; 8.49 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months |
-20.79; -18.79; -13.11; -21.08; 8.58; 12.44 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months |
52.98; 52.37; 33.25; 59.37; 56.71; 82.94 | — |
| SECONDARY Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months |
7.40; 193.91; 1.67; 187.37; 58.76; 188.50 | — |
Summary
This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib [MK-0822]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or 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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00112437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.