None listed
Conditions
Interventions
Group 1 - MK-0822 Type of group
In this extension, patients randomized to 3 mg of MK-0822 or placebo in the base study (004-02) will receive 50 mg MK-0822 once a week. Patients randomized to 10 mg, 25 mg or 50 mg weekly in the baseline study will continue with the treatment assigned in Year 3 (i.e., 50 mg of MK-0822 or placebo once a week).
Group name:Group 2 Type of group
In this extension, patients randomized to 3 mg of MK-0822 or placebo in the base study (004-02) will receive 50 mg MK-0822 once a week. Patients randomized to 10 mg, 25 mg or 50 mg weekly in the baseline study will continue with the treatment assigned in Year 3 (i.e., 50 mg of MK-0822 or placebo once a week).
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Female
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • The patient has withdrawn from Protocol 004-11 for any reason before completing the Extension of Year 3.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage change in lumbar spine BMD (relative to baseline) at 12, 24, 36, 60, 120 Months Measure:Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12, 24, 36, 60, 120 Months Timepoints:At baseline and 12, 24, 36, 60, 120 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. Measure:Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months) Timepoints:Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug) ; Outcome name:An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. Measure:Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months) Timepoints:Years 6-10 (up to 60 months) ; Outcome name:Percentage change in Total Hip, Femoral Neck, Trochanter, Total Body, Distal Forearm BMD (relative to baseline) at 12, 24, 36 months Measure:Percentage Change From Baseline in Total Hip, Femoral Neck, Trochanter, Total Body, Distal Forearm BMD at 12, 24, 36 Months Timepoints:Baseline and 12, 24, 36 Months ; Outcome name:Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12, 24, 36 Months Measure:Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12, 24, 36 Months Timepoints:Baseline and 12, 24, 36 Months ; Outcome name:Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12, 24, 36 Months. Measure:Percentage Change From Baseline in Biochemical Marker of Bone Turno | — |
Countries
Australia, Austria, Chile, Colombia, Denmark, France, Mexico, Netherlands, New Zealand, Norway, Sweden, Switzerland, United Kindgdom, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed