A 24-MONTH EXTENSION FOR: A RANDOMIZED, DOUBLE BLIND, CONTROLLED PLACEBO STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF MK-0822 (KATEPSIN-K INHIBITOR) IN THE TREATMENT OF POST-MENOPAUSE WOMEN WITH OSTE
- Conditions
- -M819M819
- Registration Number
- PER-139-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• The patient has met the initial inclusion criteria and has not met any of the exclusion criteria of Protocol 004-11. Note: There is no specific BMD T score required for eligibility in this extension study on Visit 18 (Month 36) or on the ISE Visit. Patients who meet the criteria for excessive bone loss should be discontinued at Visit 18 (see section 3.2.3.6 for details).
• The patient has participated and completed the 36 months of treatment specified in Protocol 004-02 and 004-11 (which will be determined at Visit 18 / Month 36).
• The patient generally has good health, based on medical history, physical examination and laboratory evaluation.
• The patient has withdrawn from Protocol 004-11 for any reason before completing the Extension of Year 3.
• The patient presented a fractured hip, spine or other fragility fracture during previous studies (004-02 and 004-11) and would prefer to receive another therapy for osteoporosis (bisphosphonates or PTH) for which she is eligible.
• The patient has used oral bisphosphonates in the last 6 months, IV bisphosphonates at any time, or has been treated with glucocorticoids 5 mg / day of prednisone or its equivalent) for more than 2 weeks in the last 6 months.
• The patient has used estrogen ± progestin, raloxifene or other SERM, tamoxifen, tibolone, or an aromatase or calcitonin inhibitor in the last 6 months.
• The patient is currently taking> 10,000 lU daily of Vitamin A (excluding beta carotene) or> 5,000 lU daily of Vitamin D.
• The patient was diagnosed with primary parathyroid disease during previous studies (004-02 and 004-11) and has elevated PTH or a serum calcium level greater than the upper limit of the normal range.
• The patient has hypocalcaemia as defined as serum calcium level of <8.5 mg / dL, when corrected for albumin, or shows evidence of secondary hyperparathyroidism.
• The patient has significant clinical or laboratory abnormalities at the baseline of this extension study that, in the opinion of the researcher, could complicate the interpretation of the study results or represent an additional risk for the patient (for example, hospitalized patients should be excluded for this reason).
• The patient suffers from cancer or presented a diagnosis of any malignancy during previous studies (004-02 and 004-11), except for squamous or basal cell skin cancer or cervical cancer in situ properly treated.
• The patient has been treated with an agent that could have an effect on the bone, including: Current use of chemotherapy or heparin, Protease inhibitors for HIV treatment at any time, Patients are taking anticonvulsants and the rates of Calcium metabolism is not within normal limits (Note: if the calcium metabolism rates [serum calcium, serum 25-hydroxyvitamin D and serum PTH] are within normal limits, the patient can be enrolled on the basis at this criterion), Current use of systemically administered azole antifungals (for example, ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole).
• The patient is, in the opinion of the investigator, mentally or legally incapacitated so that the informed consent cannot be obtained, or the patient cannot read or cannot understand the written material.
• The patient has participated in the study of an investigational drug other than Protocol 004-11 within the last 30 days.
• The patient is currently a recreational or illicit drug user or has a recent history of drug or alcohol abuse or dependence.
• The patient demonstrates that she does not comply with the procedures required in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Percentage change in lumbar spine BMD (relative to baseline) at 12, 24, 36, 60, 120 Months<br><br>Measure:Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12, 24, 36, 60, 120 Months<br>Timepoints:At baseline and 12, 24, 36, 60, 120 Months<br>
- Secondary Outcome Measures
Name Time Method