A Study to Evaluate the Effect of Treatment with AMG 785 in Postmenopausal Women with Osteoporosis Previously Treated with BisphosphonateTherapy
- Conditions
- Post Menopausal OsteoporosisMedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2012-002948-24-ES
- Lead Sponsor
- Amgen, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 400
- Ambulatory, postmenopausal women, aged => 60 to =< 90 at randomization. Postmenopause is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening.
- Received oral bisphosphonate therapy at a dose approved for postmenopausal osteoporosis for at least 3 years immediately prior to screening.
- At least 75% compliant (as reported by the subject) with bisphosphonate administration over the previous 3 years immediately prior to screening.
- At least 75% compliant (as reported by the subject) with alendronate (70 mg weekly or equivalent) administration during the 1 year immediately prior to screening.
- BMD T-score =< -2.50 at the lumbar spine, total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans.
- History of nonvertebral fracture after age 50, or vertebral fracture.
- At least 2 vertebrae in the L1-L4 region and at least one hip that are evaluable by DXA
- 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
- Use of the following agents affecting bone metabolism:
? Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor: at any time
? IV bisphosphonates: any dose received within 5 years prior to
randomization
? Denosumab: dose received within 18 months prior to randomization
? TPTD or any PTH analogs: more than 12 months of cumulative use or dose received within 12 months prior to randomization
? Systemic oral or transdermal estrogen, SERMs, activated vitamin D3 (1,25-dihydroxyvitamin D3), vitamin K2, or calcitonin: more than 1 month of cumulative use within 6 months prior to randomization
? 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 (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget?s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing?s disease, hyperprolactinemia, and malabsorption syndrome
- 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 hyper- or hypocalcemia, defined as albumin adjusted serum calcium outside the normal range, as determined by the central laboratory
- Current, uncontrolled hyper- or hypothyroidism, defined as thyroid-stimulating hormone and thyroxine outside of the normal range, per subject report or chart review
- Current, uncontrolled, hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review
- Subjects 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 transplants
- Known to have human immunodeficiency virus hepatitis C virus, or hepatitis B infection
- Hypersensitivity to TPTD or any of the excipients (eg, glacial acetic acid, sodium acetate, mannitol, metacresol, hydrochloric acid, sodium hydroxide) TPTD-related exclusion criteria (for all subjects)
- Severe renal impairment, (as assessed by the central laboratory based on a derived creatinine clearance of < 35 mL/min using the Modification of Diet in Renal Disease equation [Levey et al, 2006]). 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 [1.212 if subject is black].
- Unexplained elevations of alkaline phosphatase (> 1.5x ULN)
- Skeletal malignancies or bone metastases
- Prior external-beam or implant radiation therapy
- Known active or recent urolithiasis
- More than
- Receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
General exclusion criteria (for all subjects)
- Other investigational procedures are excluded.
- Malignancy within the last 5 years, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
- Known sensitivity to any of the products or known intolerance to any of the products or components to be administer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method