The purpose of this study is to find out more about the efficacy and safetyof denosumab produced by two different processes in postmenopausalwomen with osteoporosis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

• Ambulatory postmenopausal women. Ambulatory is defined as women who are able to walk, not bedridden; postmenopause is defined as no vaginal bleeding or spotting for at least 12 months prior to screening.
• Age = 55 years
• Screening bone mineral density (g/cm2) values (by DXA) at the
lumbar spine values equal to or less than 0.880 GE Lunar, 0.772 Hologic.
Screening bone mineral density (g/cm2) values (by DXA) at the
total hip values equal to or less than 0.693 GE Lunar, 0.637 Hologic.
Screening bone mineral density (g/cm2) values (by DXA) at the
femoral neck values equal to or less than 0.692 GE Lunar, 0.558 Hologic.
Both the initial and the repeat DXA assessments at baseline of the
lumbar spine OR the total hip OR the femoral neck must meet the above eligibility criteria.
Eligibility will be determined by a local reading of the DXAs at the
investigator's site. At least 2 lumbar vertebrae must be evaluable by
DXA.
• Subject's legally acceptable representative has provided informed
consent prior to any study-specific activities/procedures being initiated
when the subject has any kind of condition that, in the opinion of the
investigator, may compromise the ability of the subject to give written
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 150

Exclusion Criteria

• Height, weight, or girth which may preclude accurate DXA
measurements
• Received other osteoporosis treatment or bone active treatment with the following guidelines:
- Administration of the following within the last 5 years
. intravenous bisphosphonate
. denosumab
. fluoride for osteoporosis
. strontium salts
. PTH or PTH derivatives
• Administration or oral bisphosphonates
. > 3 years cumulatively, OR
. > 3 months and = 3 years cumulatively, unless treatment was
discontinued = 1 year prior to screening
• Administration of any of the following treatment within the last 3
months:
. SERM (selective estrogen receptor modulator)
. tibolone
. anabolic steroids or testosterone
. glucocorticosteroids (=5 mg prednisone equivalent per day for > 10
days or a total cumulative dose of = 50 mg)
. systemic hormone replacement therapy (HRT) (subjects stable on HRT
for > 3 months prior are permitted)
. antisclerostin antibody
. calcitonin
. other bone active drugs including anticonvulsants (except benzodiazepines, gabapentin) and heparin
. cathepsin K inhibitor
. chronic systemic ketoconazole, androgens, adreno corticotrophic
hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors,
gonadotropin releasing hormone agonists
• Evidence of history of any of the following:
. Current uncontrolled hypo- or hyperthyroidism (subjects who have
controlled hypo- or hyperthyroidism may be eligible, provided that they
have been on a stable therapy for at least 3 months (per subject
report)).
. hypo- or hyperparathyroidism
. known to have tested positive for human immunodeficiency virus,
hepatitis C virus, or hepatitis B surface antigen
. osteomalacia (chart review)
. osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive
dental procedures (eg, dental implants, oral surgery in the past 6
months), poor oral hygiene, periodontal and/or pre-existing dental
disease
. recent tooth extraction (within 6 months of screening visit)
. Paget's disease of bone (subject report or chart review)
. Rheumatoid arthritis
. other bone diseases which affect bone metabolism (eg, osteopetrosis,
osteogenesis imperfecta) (chart review)
• Vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL)
• Creatinine clearance (calculated using the Cockcroft-Gault equation)
of < 30 mL/min, or evidence of acute renal impairment
• Abnormalities of the following per central laboratory reference
ranges:
. hypocalcemia or hypercalcemia
. elevated transaminases = 2.0 x upper limits of normal (ULN)
• History of any solid organ or bone marrow transplant
• Malignancy within the last 5 years (except squamous cell carcinoma,
basal cell carcinoma, or cervical or breast ductal carcinoma in situ)
• Contraindicated or poorly tolerant of denosumab therapy;
contraindications include
. hypocalcemia
. hypersensitivity to drug or any component of the drug
• Known intolerance to calcium or vitamin D supplements
• Self reported alcohol or drug abuse within 12 months prior to
screening
• Any disorder that compromises ability to give truly informed consent
for participation in this study
• Currently enrolled in or has not yet completed at least 1 month since
ending other investigational device or drug trial(s), or subject is
receiving other investigational agent(s)
• Subject has known sensitivity to any of the products to be
administered during dosing
• Subject likely to not be available to complete all protocol-required
stu

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

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