A 5-Year Open Label Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in the Treatment of Postmenopausal Women with Osteoporosis - Cat-K II b Osteoporosis Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 90

Inclusion Criteria

1) Patient has met all initial inclusion criteria and has not met any of the exclusion criteria of Protocol 004-22. Note: There is no specific BMD T-score required for eligibility in this extension study at Visit 27 (Month 60) or at Visit 27E. Patients who meet excessive bone loss criteria at Visit 27 should be discontinued (see Section 3.2.3.6 for details).
2) Patient has participated in and completed 60 months of treatment in Protocols 004-02, 004-11, and 004-22 (to be determined at Visit 27/Month 60).
3) Patient is in generally good health, based on medical history, physical examination, and laboratory evaluation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient may not enter the extension study if:
1) Patient has withdrawn from Protocol 004-22 for any reason prior to completing 60 months of treatment.
2) Patient experienced a hip, spine, or other fragility fracture during the previous studies (004-02, 004-11 and 004-22) and would prefer to take other osteoporosis therapy (bisphosphonates or PTH) for which she is eligible.
Note: A fragility fracture is defined as a vertebral or non-vertebral fracture, excluding fingers, toes, or skull, that occurs when a person falls from a standing height or less, or a fracture sustained without falling, such as a vertebral fracture following coughing; these fractures indicate reduced bone strength, as normal-strength bone should be able to withstand this degree of load.
3) Patient was diagnosed with primary parathyroid disease during the previous studies (004-02, 004-11 and 004-22) and has an elevated PTH or a serum calcium level greater than the upper limit of normal range.
4) Patient has hypocalcemia as defined as serum calcium <8.5 mg/dL, when corrected for albumin, or evidence of secondary hyperparathyroidism.
5) Patient has significant clinical or laboratory abnormalities at the baseline of this extension study (Visit 27/Month 60) 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).
6) Patient has cancer or had a diagnosis of any malignancy during the previous studies (004-02, 004-11 and 004-22), except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
7) Patient is taking Vitamin A (excluding beta carotene) >10,000 IU daily or
Vitamin D >5,000 IU daily.
8) Patient has received treatment that may have an effect on bone, including, but not limited to (refer to Appendix 6.6):
a) Current use of chemotherapy or heparin
b) Protease inhibitors for HIV treatment at any time
c) Patient is taking anti-seizure medication, and indices of calcium metabolism are not within normal limits (Note: if serum calcium is within normal limits, the patient may enroll based on this criterion)
9) Current use of systemically administered azole antifungals (for example, systemic ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole) and other strong CYP3A4 inhibitors, such as clarithromycin and telithromycin (note: azithromycin is permitted).
10) Patient is currently treated with strong CYP3A4 inducers (e.g., rifampin [rifampicin], phenobarbital, barbiturates, carbamazepine, phenytoin, St. John's wort, nevirapine, efavirenz, and etravirine).
11) Patient is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the patient cannot read or comprehend the written material.
12) Patient has participated in an investigational drug study other than Protocol 004-22 within the past 30 days.
13) Patient is currently a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
14) Patient demonstrates noncompliance in following the procedures required in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A Study to Assess the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) vs placebo in the Treatment of Women With Osteoporosis

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,

Updated 4/11/2016