Study to Assess the Efficacy and Safety of AMG785 Treatment in Postmenopausal Women With Osteoporosis

Phase 1

• Conditions: Postmenopausal Osteoporosis; MedDRA version: 14.1Level: 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-ES
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-13
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 5600

Inclusion Criteria

- Ambulatory postmenopausal women, age >= 60 to <= 90 years at
randomization
- 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.
- 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5400

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, fluoride (for osteoporosis), odanacatib (MK-0822)
IV bisphosphonates: dose received within 5 years prior to randomization
Oral bisphosphonates
? More than 3 years of cumulative use
? Any dose received within 6 months prior to randomization
? More than 1 month of cumulative use between 6 and 12 months prior to randomization
- Denosumab: dose received within 18 months prior to randomization
- Teriparatide or any PTH analogs: dose received within 12 months prior to randomization
- Systemic oral or transdermal estrogen, SERMs, or calcitonin
- Androgen deprivation or hormonal ablation therapy
- Tibolone, cinacalcet: dose received within 3 months prior to
randomization
- Systemic glucocorticosteroids: ? 5 mg prednisone equivalent per day for more than 10 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
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
- Possible diagnosis of multiple myeloma or related myeloproliferative disorder
- Contraindicated or intolerant to denosumab therapy

Study & Design

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