Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Phase 1

• Conditions: Postmenopausal Osteoporosis; MedDRA version: 19.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2011-001456-11-DK
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-02
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 6600

Inclusion Criteria

- Ambulatory postmenopausal women, age = 55 to = 90 years at
randomization. Postmenopause is defined as no vaginal bleeding or
spotting for 12 consecutive months prior to screening.
- BMD T-score = -2.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans and using data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES) 1998.
- At least 2 vertebrae in the L1-L4 region and at least one hip are evaluable by DXA, as assessed by the principal investigator, eg, based on lateral spine x-rays
- Subject has provided informed consent
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6360

Exclusion Criteria

- BMD T-score = -3.50 at the total hip or femoral neck
- History of hip fracture
- Any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures

Use of the following agents affecting bone metabolism:
- Strontium ranelate or fluoride (for osteoporosis): more than one month of cumulative use within 5 years prior to randomization
- IV bisphosphonates:
• Zoledronic acid:
- any dose received within 3 years prior to randomization
- more than 1 dose received within 5 years prior to randomization
• IV ibandronate or IV pamidronate:
- any dose received within 12 months prior to randomization
- more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization
- Oral bisphosphonates
• More than 3 years of cumulative use, unless last dose received = 5 years prior to randomization
• Any dose received within 3 months prior to randomization
• More than 1 month of cumulative use between 3 and 12 months 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:
• any dose received within 3 months prior to randomization
• more than 1 month of cumulative use between 3 and 12 months prior to randomization
- Systemic oral or transdermal estrogen or SERMs, or calcitonin: 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 that may interfere with the interpretation of the results
- History of solid organ or bone marrow transplants
- History of osteonecrosis of the jaw
- Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory.laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the upper limit of normal (ULN) as assessed by the central laboratory.
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
- Possible diagnosis of multiple myeloma or related lymphoproliferative disorder
- Contraindicated or intolerant to denosumab therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified