Study to Assess the Efficacy and Safety of AMG785 Treatment Compared to Alendronate 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: EUCTR2011-003142-41-GR
• Lead Sponsor: Amgen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-25
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

4.1.1 Ambulatory postmenopausal women, age = 60 to = 90 years at randomization
4.1.2 BMD T-score = -2.50 at the total hip or femoral neck and at least one moderate (SQ2) or severe (SQ3) vertebral fracture, as assessed by the central imaging vendor at the time of screening, based on DXA scans and lateral spine x-rays.
4.1.3 At least one hip is evaluable by DXA, as assessed by the principal investigator
4.1.4 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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3850

Exclusion Criteria

4.2.1 Strontium, fluoride (for osteoporosis), odanacatib (MK-0822): at any time
4.2.2 Intravenous (IV) bisphosphonates: dose received within 5 years prior to randomization
4.2.3 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
4.2.4 Denosumab: dose received within 18 months prior to randomization
4.2.5 Teriparatide or any PTH analogs: dose received within 12 months prior to randomization
4.2.6 Systemic oral or transdermal estrogen, SERMs, or calcitonin: more than 1 month of cumulative use within 6 months prior to randomization
4.2.7 Androgen deprivation or hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization
4.2.8 Tibolone or cinacalcet: dose received within 3 months prior to randomization
4.2.9 Systemic glucocorticosteroids: = 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization
4.2.10 History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome
4.2.11 History of solid organ or bone marrow transplants
4.2.12 Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as assessed by the central laboratory. Vitamin D repletion will be permitted and subjects may be rescreened once 4.2.13 Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory
4.2.14 Current, uncontrolled hyper- or hypothyroidism, defined as thyroidstimulating hormone outside of the normal range, per subject report or chart review
4.2.15 Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review
4.2.16 Possible diagnosis of multiple myeloma or related myeloproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory
4.2.17 Exclusion criteria related to contraindications or possible signs of intolerance to ALN; contraindications and potential signs of intolerance for
ALN therapy include:
• Hypocalcemia (as defined in 4.2.13)
• Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 30 minutes
• Hypersensitivity to ALN or other constituents of ALN tablets
• Increased risk of aspiration
• Pregnancy and lactation
• Other contraindications to ALN based on the country-specific product insert applicable to the specific study center
• Significantly impaired renal function (as assessed by the central laboratory based on a derived creatinine clearance of < 35 mL/min using the Modification of Diet in Renal Disease. The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 175 x
[Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black].
4.2.18 General
• Subject is currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
• Subject has previously entered th

Study & Design

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