Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00043186 |
To determine the effect of AMG 162 treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that AMG 162 SC injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.
Condition | Intervention | Phase |
---|---|---|
Low Bone Mineral Density |
Drug: Placebo Drug: Denosumab Drug: Active comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density |
Enrollment: | 412 |
Study Start Date: | May 2002 |
Study Completion Date: | June 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
30 mg sc q 3 months: Experimental
AMG 162: 30 mg SC every 3 months until month 21; placebo SC every 6 months at month 24 and month 30; 60 mg SC every 6 months at month 36 and month 42
|
Drug: Denosumab
AMG 162: 14 60, and 100 mg SC every 6 months until month 21 (alternating with placebo every 3 months); 60 mg SC every 6 months beginning month 24 through 42 AMG 162: 210 mg SC every 6 months until month 21; (alternating with placebo every 3 months); placebo every 6 months beginning month 24 through 42 AMG 162: 30 mg SC every 3 months until month 21; placebo SC every 6 months at month 24 and month 30; 60 mg SC every 6 months at month 36 and month 42 AMG 162: 6 and 14 mg SC every 3 months until month 21; 60 mg SC every 6 months beginning month 24 through 42 |
210 mg: Experimental
AMG 162: 210 mg SC every 6 months until month 21; (alternating with placebo every 3 months); placebo every 6 months beginning month 24 through 42
|
Drug: Denosumab
AMG 162: 14 60, and 100 mg SC every 6 months until month 21 (alternating with placebo every 3 months); 60 mg SC every 6 months beginning month 24 through 42 AMG 162: 210 mg SC every 6 months until month 21; (alternating with placebo every 3 months); placebo every 6 months beginning month 24 through 42 AMG 162: 30 mg SC every 3 months until month 21; placebo SC every 6 months at month 24 and month 30; 60 mg SC every 6 months at month 36 and month 42 AMG 162: 6 and 14 mg SC every 3 months until month 21; 60 mg SC every 6 months beginning month 24 through 42 |
6 and 14 mg q 3 months: Experimental
AMG 162: 6 and 14 mg SC every 3 months until month 21; 60 mg SC every 6 months beginning month 24 through 42
|
Drug: Denosumab
AMG 162: 14 60, and 100 mg SC every 6 months until month 21 (alternating with placebo every 3 months); 60 mg SC every 6 months beginning month 24 through 42 AMG 162: 210 mg SC every 6 months until month 21; (alternating with placebo every 3 months); placebo every 6 months beginning month 24 through 42 AMG 162: 30 mg SC every 3 months until month 21; placebo SC every 6 months at month 24 and month 30; 60 mg SC every 6 months at month 36 and month 42 AMG 162: 6 and 14 mg SC every 3 months until month 21; 60 mg SC every 6 months beginning month 24 through 42 |
open label reference group: Active Comparator
Fosamax 70 mg oral weekly for 24 months. No treatment through month 48
|
Drug: Active comparator
Fosamax 70 mg oral weekly for 24 months. No treatment through month 48
|
blinded control group: Placebo Comparator
placebo sc every 3 months until month 21 then beginning at month 24 every 6 months until month 42
|
Drug: Placebo
placebo sc every 3 months until month 21 then beginning at month 24 every 6 months until month 42
|
14, 60 & 100 mg: Experimental
AMG 162: 14 60, and 100 mg SC every 6 months until month 21 (alternating with placebo every 3 months); 60 mg SC every 6 months beginning month 24 through 42
|
Drug: Denosumab
AMG 162: 14 60, and 100 mg SC every 6 months until month 21 (alternating with placebo every 3 months); 60 mg SC every 6 months beginning month 24 through 42 AMG 162: 210 mg SC every 6 months until month 21; (alternating with placebo every 3 months); placebo every 6 months beginning month 24 through 42 AMG 162: 30 mg SC every 3 months until month 21; placebo SC every 6 months at month 24 and month 30; 60 mg SC every 6 months at month 36 and month 42 AMG 162: 6 and 14 mg SC every 3 months until month 21; 60 mg SC every 6 months beginning month 24 through 42 |
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
4.1 Inclusion Criteria 4.1.1 Women not more than 80 years old on date of randomization 4.1.2 At least 1 year postmenopausal on date of randomization 4.1.3 Ambulatory 4.1.4 If ≤ 60 years old or post bilateral oophorectomy based on medical history, will require serum FSH > 50mU/mL or serum estradiol < 20 pg/mL to be eligible; 4.1.5 Low bone mineral density (BMD t-score ≤ -1.8 at any one of the following sites: lumbar spine, femoral neck, or total hip; BMD t-scores must not be lower than -4.0 at the lumbar spine, or -3.5 at the femoral neck or total hip). Refer to Table 3 in Section 7.11.1 for Hologic and Lunar densitometer-specific BMD values, and more specific information. 4.1.6 Ethical - Before any study specific procedure, including the screening DXA, the subject must give informed consent for participation in the study (see Section 12.2). 4.2 Exclusion Criteria 4.2.1 Fluoride treatment for osteoporosis within the last 2 years before the enrollment date; 4.2.2 Bisphosphonate use within the last 12 months before the enrollment date; 4.2.3 Administration of the following medications within the last 6 months before enrollment date:
a) Systemic hormone replacement therapy b) Selective estrogen receptor modulators (SERMs) c) Calcitonin d) Calcitriol 4.2.5 Evidence of any of the following conditions per subject self report or medical chart review:
Renal disease (creatinine clearance <= 35 mL/min using the following equation):
Creatinine Clearance = 0.85 [(140 - age in years) x (weight in kg)] [72 x serum creatinine (mg/dL)]
4.2.8 Any organic or psychiatric disorder, serum chemistry, or hematology, which, in the opinion of the investigator, may prevent the subject from completing the study or interfere with the interpretation of the study results. 4.2.9 Self-reported alcohol or drug abuse within the previous 12 months. 4.2.10 Any disorder that compromises ability to give truly informed consent for participation in this study. 4.2.11 Prior administration of AMG 162. 4.2.12 Known sensitivity or contraindication to Fosamax. 4.2.13 Known sensitivity or contraindication to tetracycline derivatives (biopsy subset subjects only).
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010223 |
Study First Received: | August 6, 2002 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00043186 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bone loss osteoporosis |
Alendronate Osteoporosis |