osteoporosis
Conditions
Interventions
Patients will receive either odanacatib 50 mg once weekly or placebo and open
label vitamin D3 5600 IU once weekly. Patients will also receive a sufficient
supply of open-label daily calcium supplem
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patient is a man between 40 and 95 years of age on the day of Randomization. 2) Patient has idiopathic osteoporosis or osteoporosis due to hypogonadism and fulfills one of the following criteria: a) Patient is a candidate for osteoporosis therapy and has BMD T-score * -2.5 at either the lumbar spine or the total hip or any hip subregion (femoral neck or trochanter) and a BMD T-score * -4.0 at all sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%).* OR b) Patient is a candidate for osteoporosis therapy and has BMD T-score * -1.5 at either the lumbar spine or the total hip or any hip subregion (femoral neck or trochanter) and a BMD T-score * -4.0 at all sites, and has one prior vertebral fracture *OR c) Patient is not a suitable candidate for, or has declined osteoporosis therapy and has BMD T-score * -2.5 at either the lumbar spine or the total hip or any hip subregion (femoral neck or trochanter) and does not have a prior vertebral fracture; or has BMD T-score * -1.5 at either the lumbar spine or the total hip or any hip subregion (femoral neck or trochanter), and has at least one prior vertebral fracture. Note: For the purpose of study inclusion, a patient may not be a suitable candidate for osteoporosis therapy, due to contraindication, established intolerance, physician*s judgment, or patient*s unwillingness. T-scores should be determined using male normative data. Only the T-scores provided by the central imaging vendor can be used to determine eligibility. Locally determined T-scores can be used to exclude patients, however, scans with borderline exclusionary T-score values should be submitted to the central imaging vendor for analysis. Note: Eligibility for this criterion is based on the absolute BMD thresholds for male T-scores that are detailed in the central imaging vendor manual. 3) Patient has lumbar spine anatomy suitable for DXA. Specifically, at least 2 vertebral bodies in the L1 to L4 region must be assessable (patient must not have significant sclerosis, degenerative joint disease, bony trauma, and sequelae or hardware from orthopedic procedures). Note, lumbar spine BMD values will be calculated from the average of all evaluable vertebrae, with a minimum requirement for 2. At the hip, at least one femoral neck site must be evaluable by DXA assessment without any sequalae or hardware from orthopedic procedures. 4) Patient understands the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 5) Patient is ambulatory. 6) Patient is able to read, understand, and complete questionnaires and diaries. Note: If a patient who understands the purpose and use of the diary cards and study questionnaires is unable to complete these without assistance, (e.g. due to visual problems, difficulty writing due to arthritis, inability to read, etc.) a family member or care-giver may assist or may complete the diary card on his behalf.
Exclusion criteria
Exclusion criteria: 1) Patient has chosen treatment with oral bisphosphonate or other agents for the treatment of osteoporosis. 2) Patient has had a prior clinical fragility hip fracture, and is a suitable candidate for osteoporosis therapy (i.e. bisphosphonates, parathyroid hormone (PTH)). 3) Patient has experienced a clinical fragility fracture (including any vertebral fracture) within 12 months, documented by medical record, or detected on the screening spine radiographs read locally, unless the patient is unwilling to take, or is not a candidate for marketed osteoporosis therapy. 4) Patient has had more than 1 prior vertebral fracture (defined as anterior, mid, or posterior height loss of > 20%) and he is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates or PTH). 5) Patient has or has had evidence of a metabolic bone disorder other than osteoporosis. 6) Patient has vitamin D deficiency, defined as serum 25-hydroxyvitamin D 2 years prior to screening are not excluded.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in this study is the percent change from baseline in BMD at the lumbar spine over 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Total hip, femoral neck, and trochanter BMD over 24 months. (2) Biochemical indices of bone resorption (serum C-Telopeptides of Type 1 collagen [s-CTx] and urine N-Telopeptides of Type 1 collagen [u-NTx]) over 24 months. (3) Lumbar spine, total hip, femoral neck, and trochanter BMD over 24 months. | — |
Countries
Netherlands
Outcome results
None listed