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

Not Applicable

Completed

• Conditions: -M80; M80

• Registration Number: PER-075-10
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• The patient has met all the 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 on Visit 27 (Month 60) or on Visit 27E. Patients who meet the criteria for excessive bone loss should be discontinued on Visit 27 (see Section 3.2.5.6 for details).
• The patient has participated and has completed 60 months of treatment in Protocols 004-2, 004-11 and 004-22 (which will be determined in Visit 27 / Month 60),
• The patient generally has good health, according to medical history, physical examination and laboratory evaluation.

Exclusion Criteria

• The patient has withdrawn from Protocol 004-22 for any reason before completing 60 months of treatment.
• The patient experienced a fracture in the hip, spine or other fragility fracture during previous studies (004-02, 004-11 and 004-22) and would prefer to receive another therapy for osteoporosis (bisphosphonates or PTH) for which She is eligible.
• The patient was diagnosed with a primary parathyroid disease during the previous studies (004-02, 004-11 and 004-22) and has an elevated PTH or serum calcium level greater than the upper limit of the normal range.
• The patient has hypocalcemia, which is defined as a serum calcium level <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 (Visit 27 / .Mcs 60) which, in the opinion of the researcher, could complicate the interpretation of the study results or represent an additional risk for patient (for example, hospitalized patients should be excluded for this reason).
• The patient has cancer or presented a diagnosis of any malignancy during previous studies (004-02, 004-11 and 004-22), except for basal cell or squamous cell skin cancer or cervical cancer treated in situ adequately.
• The patient is taking> 10,000 lU daily of Vitamin A (with the exception of beta carotene) or> 5,000 lU daily of Vitamin D.
• The patient has received a treatment that could have an effect on the bone, which includes, without limitation: a) Current use of chemotherapy or heparin. b) Protease inhibitors for the treatment of HIV at any time. c) The patient is taking an anticonvulsant, and calcium metabolism rates are not within normal limits (Note: if serum calcium is within normal limits, the patient can enroll based on this criterion) .
• Current use of systemic azole antifungals (eg, ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole and systemic voriconazole) and other strong CYP3A4 inhibitors, such as clarithromycin and telithromycin (note: azithromycin is allowed)
• The patient is currently receiving treatment with strong inducers of CYP3A4 (for example, rifampin [rifampicin], phenobarbital, barbiturates, carbamazepine, phenytoin, St. John´s wort, nevirapine, efavirenz and etravirine).
• The patient is, in the opinion of the investigator, legally incompetent or mentally disabled, so that informed consent cannot be obtained, or the patient cannot read or cannot understand written material.
• The patient has participated in a study with an investigational drug other than Protocol 004-22 within the last 30 days.
• The patient currently uses recreational or illegal drugs, or has had a recent history of drug addiction or alcoholism or drug or alcohol dependence.
• The patient demonstrates failure to follow the procedures required in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified