A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis. FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months)
- Conditions
- Treatment of postmenopausal osteoporosisMedDRA version: 8.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2004-000138-35-GB
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 7869
- Postmenopausal, ambulatory women, between 60 and 90 years old
- BMD T-score < –2.5 at one or more of the following regions: the lumbar spine or total hip
- Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- BMD T-score < -4.0 at one or more of the following regions: Lumbar spine or total hip
- Oral bisphosphonate treatment for osteoporosis:
Ineligible if used for 3 or more years cumulatively;
If used for >3 months, but = 3 years, at least a one year period since last dose is necessary for eligibility;
If used = 3 months at any time in the past, subject is eligible.
- Administration of intravenous bisphosphonate, fluoride or strontium for osteoporosis within the last 5 years
- Administration of any of the following treatments within the last 6 weeks:
a)PTH or PTH derivatives, eg, teriparatide
b)Anabolic steroids or testosterone
c)Glucocorticosteroids (> 5 mg prednisone equivalent per day for more than 10 days)
d)Systemic hormone replacement therapy
e)Selective estrogen receptor modulators (SERMs), eg, raloxifene
f)Tibolone
g)Calcitonin
h)Calcitriol
- Evidence of any of the following per patient report, chart review, DXA, or X-ray review:
a)Hyper or hypothyroidism; patients on stable thyroid treatment with a normal TSH will be allowed
b)Current hyper- or hypoparathyroidism
c)Current hypocalcemia (albumin adjusted serum calcium below 2.13 mmol/L [8.5 mg/dL])
d)Vitamin D deficiency [(25) hydroxy Vitamin D level < 12 ng/mL)
e)Rheumatoid arthritis
f)Paget’s disease
g)Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
h)Any bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
i)Malabsorption syndrome
j)Height, weight and girth which may preclude accurate DXA measurements
k)Advanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment
l)Any severe or more than 2 moderate vertebral fractures on spinal X-rays (see section 7.9 of protocol)
m)Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA
- Known sensitivity to mammalian cell derived drug products
- Any organic or psychiatric disorder, or laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
- Evidence of alcohol or substance-abuse within the last 12 months that the investigator believes would interfere with understanding or completing the study
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- For biopsy sub study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
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