A Randomized, Double-Blind Study to Compare the Efficacy of Treatment withDenosumab versus Alendronate Sodium in Postmenopausal Women with LowBone Mineral Density

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1100

Inclusion Criteria

-Ambulatory postmenopausal women based on medical history.
-BMD values (g/cm2), assessed at the local site that correspond to T-score = -2.0
at the lumbar spine OR total hip as follows:
a) For the lumbar spine, the BMD values (g/cm2) must be =0.940 (GE lunar) or =0.827 (Hologic)
b) For the total hip, the BMD values (g/cm2) must be =0.756 (GE lunar) or =0.698 (Hologic)
-Provide the appropriate written informed consent before any study-specific
procedure.
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

Exclusion Criteria

-Any disorder that compromises the ability of the subject to give written informed consent and /or comply with study procedures
-Evidence of any of the following:
a) Hyper- or hypothyroidism
b) Current hyper- or hypoparathyroidism
c) Elevated transaminases
d) Significantly impaired renal function as determined by serum creatinine = 2.0 mg/dL
e) Current hypo- or hypercalcemia based on the central laboratory reference ranges
f) Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication
g) Rheumatoid Arthritis, Paget’s disease, Cushing’s disease, hyperprolactinemia, or cirrhosis of the liver
h) Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
i) Malignancy (except fully resected cutaneous basal cell or squamous cell
carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
j) Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
k) Malabsorption syndrome or any gastrointestinal disorders that are associated
with malabsorption
-Received any solid organ or bone marrow transplant.
-Vitamin D deficiency (25(OH) vitamin D level < 12 ng/mL).
-Any 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.
-Contraindicated or poorly tolerant of ALN therapy.
-Known sensitivity to mammalian cell derived drug products.
-Known intolerance to calcium supplements.
-Administration of intravenous bisphosphonate, or fluoride (except for dental
treatment) or strontium ranelate.
-Oral bisphosphonate treatment:
• = 3 months cumulatively in the past 2 years, OR
• = 1 month in the past year, OR
• Any use during the 3-month period prior to randomization
-PTH or PTH derivatives (eg, teriparatide) within the last year.
-Administration of any of the following treatments within 3 months of randomization:
a) Any SERM (eg, raloxifene)
b) Tibolone
c) Anabolic steroids or testosterone
d) Glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10
days)
e) Systemic (oral, transdermal, topical) hormone replacement therapy (local
vaginal estrogen preparation will be allowed)
f) Calcitonin
g) Calcitriol or vitamin D derivatives
h) Other bone active drugs including anti-convulsives (except benzodiazepines)
and heparin
i) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum,
lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone
agonists
-Height, weight or girth which may preclude accurate DXA measurements.
-Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA measurements.
-Both hips not evaluable by DXA (eg, history of bilateral hip replacement or pins in
both hips).
-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.
-Any physical or psychiatric disorder 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 which the
investigator believes would interfere with understanding or completing the study.

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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