A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
- Conditions
- Postmenopausal osteoporosis10005959
- Registration Number
- NL-OMON43694
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
- Ambulatory postmenopausal women, age * 55 to * 90 years
- Subject meets at least one of the following BMD and fracture criteria
* BMD T-score * -2.50 at the total hip or femoral neck (as assessed by the central imaging vendor based on DXA scans and using data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES) 1998) AND EITHER at least one moderate (SQ2) or severe (SQ3) vertebral fracture OR at least 2 mild (SQ1) vertebral fractures
OR
* BMD T-score * -2.00 at the total hip or femoral neck AND EITHER at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR a fracture of the proximal femur.
Refer to Sections 7.13 and 7.14 for details.
- At least one hip is evaluable by DXA, as assessed by the principal investigator
- Subject has provided informed consent
- Use of the following agents affecting bone metabolism (4.2.1 through 4.2.9):
* Strontium ranelate, or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization
* Intravenous (IV) bisphosphonates
o Zoledronic acid: any dose received within 3 years prior to randomization
o more than 1 dose received within 5 years prior to randomization
* IV ibandronate or IV pamidronate:
o any dose received within 12 months prior to randomization
o more than 3 years of cumulative use, unless last dose received * 5 years prior to randomization
* Oral bisphosphonates:
o any dose received within 3 months prior to randomization
o more than 1 month of cumulative use between 3 and 12 months prior to randomization
o more than 3 years of cumulative use, unless last dose received * 5 years prior to randomization
* Denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822): any dose received within 18 months prior to randomization
* Teriparatide or any PTH analogs:
o any dose received within 3 months prior to randomization
o more than 1 month of cumulative use between 3 and 12 months prior to randomization
* Systemic oral or transdermal estrogen or SERMs: more than 1 month of cumulative use within 6 months prior to randomization
* Hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization
* Tibolone, cinacalcet, or calcitonin: any dose received within 3 months prior to randomization
* Systemic glucocorticosteroids: * 5 mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization;- History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget*s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing*s disease, hyperprolactinemia, and malabsorption syndrome;
- History of solid organ or bone marrow transplants;
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory;
- Current, uncontrolled hyper- or hypothyroidism, per subject report or chart review. Uncontrolled hyperthyroidism is defined as TSH and T4 outside the normal range. Uncontrolled hypothyroidism is defined as TSH > 10;
- Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism, per subject report or chart review. Uncontrolled hyperparathyroidism is defined as: PTH outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal in normocalcemic subjects;
- Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory (electrophoresis results within 6 months prior to signing consent will be acceptable);
- Exclusion criteria related to contraindications or possible signs of intolerance to ALN (see protocol section 4.2.17)
- General exclusion criteria as described in protocol section 4.2.18
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For the primary analysis periode:<br /><br>- To assess the effect of AMG 785 treatment for 12 months followed by ALN<br /><br>treatment compared with ALN treatment alone on the subject incidence of<br /><br>clinical fracture (nonvertebral fracture and clinical vertebral fracture) in<br /><br>women with PMO;<br /><br>- To assess the effect of AMG 785 treatment for 12 months followed by ALN<br /><br>treatment compared with ALN treatment alone on the subject incidence of new<br /><br>vertebral fracture in women with PMO.</p><br>
- Secondary Outcome Measures
Name Time Method