None listed
Conditions
Interventions
MK0822 Type of group
All eligible patients will receive 50 mg odanacatib once a week during the 60 months of treatment. Odanacatib will be provided in the form of single 50 mg tablets. All patients will be instructed to take the study drug regardless of food.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Female
Age
55 Years to 80 Years
Inclusion criteria
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
Exclusion criteria: • The patient has withdrawn from Protocol 004-22 for any reason before completing 60 months of treatment.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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:BMD will be measured through dual energy X-ray absorptiometry (DXA) scans on the hip (total, femoral neck, trochanter), lumbar spine and distal third of the radius at all of the following assessment points: Months 72, 84 , 96, 108 and 120. Measure:Percent change from baseline in BMD of the lumbar spine Timepoints:Months 72, 84 , 96, 108 and 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:BMD will be measured through dual energy X-ray absorptiometry (DXA) scans on the hip (total, femoral neck, trochanter), lumbar spine and distal third of the radius at all of the following assessment points: Months 72, 84 , 96, 108 and 120. Measure:The percentage change from baseline in BMD measurements in the total hip, femoral neck, hip trochanter and distal third of the radius Timepoints:Months 72, 84 , 96, 108 and 120. ; Outcome name:Bone replacement biochemical indices will be measured in Months 72, 84, 96, 108 and 120. These indices include serum-specific bone-alkaline alkaline phosphatase (s-BSAP) and N-terminal propeptide of serum Type 1 collagen (s-PlNP ), urine telopeptides N of Type I collagen in urine (u-NTx), telopeptides C of serum Type 1 collagen (s-CTx), cross-linked carboxyterminal telopeptide of serum type I collagen (ICTP) and isoform 5b of tartrate acid phosphatase - serum resistant (TRAP 5b) Measure:Change with respect to baseline in the biochemical markers of bone resorption (s-CTX, u-NTx, s-TRAP 5b and s-lCTP) and bone formation (s-BSAP, s-PlNP), Timepoints:During the study | — |
Countries
Denmark, Peru, Sweden, United Kindgdom
Contacts
Public ContactJORGE TIMOTEO
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed