An international study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis

Phase 1

Conditions: male osteoporosis
MedDRA version: 19.0Level: PTClassification code 10031282Term: OsteoporosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-005551-32-PL

Lead Sponsor: Amgen, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 225

Inclusion Criteria

- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- Ambulatory male subjects = 55 years to = 90 years of age, at the time of enrollment
- Increased risk of fracture, defined as:
? * BMD T-score = -2.50 at the lumbar spine, total hip, or femoral neck, based on DXA scans
OR
? * BMD T-score = -1.50 at the lumbar spine, total hip, or femoral neck, based on DXA scans and a history of fragility nonvertebral fracture or vertebral facture (thoracic or lumbar)
- Subject has at least 2 evaluable vertebrae in the L1 to L4 region, as assessed by the principal investigator or designee
- Subject has at least 1 evaluable hip, as assessed by the principal investigator or designee
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

- BMD T-score = -3.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
- History of hip fracture
- Oral bisphosphonates:
? * any dose received within 3 months prior to randomization
* more than 1 month of cumulative use between 3 and 12 months prior to randomization
? * more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization
- Intravenous (IV) bisphosphonates
? * Zoledronic acid:
o any dose received within 3 years prior to randomization
o more than 1 dose received within 5 years prior to randomization
? IV ibandronate, IV pamidronate, or IV alendronate:
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
- Teriparatide or any parathyroid hormone (PTH) analogs:
? * any dose received within 3 months prior to randomization
? * more than 1 month of cumulative use between 3 and 12 months prior to randomization
- Strontium ranelate, or fluoride (for osteoporosis): more than 1 month of cumulative use within 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
- 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
- Anabolic steroids: any use within 6 months prior to randomization. Testosterone is permitted providing treatment was not begun within the 6 months prior to randomization
- Hormonal ablation therapy: more than 1 month of cumulative use within 6 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, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome
- Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget’s disease, sclerosteosis, and osteopetrosis)
- History of solid organ or bone marrow transplant
- Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/ml as determined by the central laboratory). Vitamin D repletion will be permitted and subjects may be rescreened
- 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 (ULN) in normocalcemic subjects
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory.
- Subject previously has entered this study or has previously participated in a study with a sclerostin antibody product
- Malignancy within the last 5 years, except non-melanoma skin cancers
- Possible diagnosis o

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of treatment with romosozumab for 12 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual energy x ray absorptiometry (DXA) in men with osteoporosis.;Secondary Objective: - To evaluate the effect of treatment with romosozumab for 12 months compared with placebo on the percent changes in DXA BMD at the total hip and femoral neck<br>- To evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in DXA BMD at the lumbar spine, total hip, and femoral neck<br>;Primary end point(s): Percent change from baseline in DXA BMD at the lumbar spine at month 12;Timepoint(s) of evaluation of this end point: month 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Percent change from baseline in DXA BMD at the femoral neck and total hip at month 12<br>- Percent change from baseline in DXA BMD at the lumbar spine, femoral neck, and total hip at month 6<br>;Timepoint(s) of evaluation of this end point: Months 6 and 12

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