E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal Osteoporosis |
|
E.1.1.1 | Medical condition in easily understood language |
Postmenopausal Osteoporosis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031285 |
E.1.2 | Term | Osteoporosis postmenopausal |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of treatment with MK-0822 50 mg once weekly on the risk of morphometrically assessed
vertebral fractures compared to placebo.
To assess the effect of treatment with MK-0822 on the risk of hip fractures compared to placebo.
To assess the effect of treatment with MK-0822 on the risk of clinical non-vertebral fractures compared to
placebo. (Note: for the purposes of this study, non-vertebral fractures are defined as fractures of the hip, pelvis,
wrist, humerus, clavicle, leg and rib). |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of treatment with MK-0822 50 mg once weekly:
on the risk of clinical vertebral fractures compared to placebo.
on height compared to placebo.
on the lumbar spine, total hip, femoral neck, trochanter and distal forearm BMD compared to placebo.
on biochemical indices of bone resorption (serum C-Telopeptides of Type 1 collagen [s-CTX] and urine NTelopeptides
of Type 1 collagen [u-NTX]) compared to placebo.To assess the effect of treatment with MK-0822
50 mg once weekly on biochemical indices of bone formation (serum bone-specific alkaline phosphatase [BSAP]
and serum-P1NP) compared to placebo.
on qualitative histomorphometry of transilial bone biopsy specimens compared to placebo.
To assess the safety and tolerability of treatment with MK-0822 50 mg once weekly compared to placebo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is a woman and is ≥ 65 years of age on the day of signing informed consent.
2. Patient meets one of the following:
a) Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score ≤-1.5
at either the total hip or femoral neck site, BMD T-score ≥-4.0 at both sites, and has one prior vertebral fracture
(defined as anterior, mid or posterior height loss of >20%). – ORb)
Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score ≤-2.5
at either the total hip or femoral neck site, BMD T-score ≥-4.0 at both sites, and does not have a prior vertebral
fracture (defined as anterior, mid or posterior height loss of >20%). – OR -
c) Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or
PTH), has BMD T-score ≤-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral
fracture (defined as anterior, mid or posterior height loss of >20%). – ORd)
Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or
PTH), and has a BMD T-score ≤-2.5 at either the total hip or femoral neck site.
3. The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic
procedures).
4. Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5
years status post bilateral oophorectomy. |
|
E.4 | Principal exclusion criteria |
1) Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip
fracture.
2) Patient has had a prior hip fracture.
3) Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months.
(Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
4) Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a
suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
5) Patient has or has had evidence of a metabolic bone disorder other than osteoporosis. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Morphometric fractures, hip fractures, and clinical non-vertebral fractures. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline, Month 6, Month 12, and yearly thereafter until the end of the 5-year doubleblind extension study |
|
E.5.2 | Secondary end point(s) |
1) Bone Mineral Density 2) Clinical non-vertebral and vertebral Fracture evaluation |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and each of the yearly timepoints up to the end of
the extension study |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 115 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Chile |
China |
Colombia |
Croatia |
Dominican Republic |
Guatemala |
Hong Kong |
India |
Japan |
Korea, Republic of |
Lebanon |
Mexico |
New Zealand |
Norway |
Peru |
Philippines |
Russian Federation |
Serbia |
South Africa |
Switzerland |
Taiwan |
Ukraine |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
When the last patient to randmonize in the base study and is enrolled in the extension complete 5 years of blinided study treatment. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |