DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Bone Mineral Density

Intervention: Placebo (Drug); Denosumab (Drug); Alendronate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

To determine the effect of denosumab 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 denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms

Secondary outcome:

Serum CTX Percent Change From Baseline at Month 12

Urine NTX/Creatinine Percent Change From Baseline at Month 12

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48

Serum CTX Percent Change From Baseline at Month 24

Serum CTX Percent Change From Baseline at Month 36

Serum CTX Percent Change From Baseline at Month 42

Serum CTX Percent Change From Baseline at Month 48

Urine NTX/Creatinine Percent Change From Baseline at Month 24

Urine NTX/Creatinine Percent Change From Baseline at Month 36

Urine NTX/Creatinine Percent Change From Baseline at Month 42

Urine NTX/Creatinine Percent Change From Baseline at Month 48

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

Total Hip Bone Mineral Density Percent Change From Baseline at Month 36

Total Hip Bone Mineral Density Percent Change From Baseline at Month 42

Total Hip Bone Mineral Density Percent Change From Baseline at Month 48

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42

Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48

Total Body Bone Mineral Density Percent Change From Baseline at Month 12

Total Body Bone Mineral Density Percent Change From Baseline at Month 24

Total Body Bone Mineral Density Percent Change From Baseline at Month 36

Total Body Bone Mineral Density Percent Change From Baseline at Month 42

Total Body Bone Mineral Density Percent Change From Baseline at Month 48

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42

Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48

Eligibility

Minimum age: N/A. Maximum age: 80 Years. Gender(s): Female.

Criteria:

Inclusion Criteria

- women not more than 80 years of age on date of randomization

- ≥ 1 year postmenopausal on date of randomization

- ambulatory

- if ≤ 60 years of age, or had or would require a bilateral oophorectomy, serum

follicle stimulating hormone (FSH) > 50 mU/mL or serum estradiol < 20 pg/mL

- low BMD (BMD T-score ≤ -1. 8 at any 1 of the following sites: lumbar spine, femoral

neck, or total hip; BMD T-scores must not have been < - 4. 0 at the lumbar spine or -

3. 5 at the femoral neck or total hip)

- before any study-specific procedure, including the screening dual X-ray

absorptiometry (DXA) scan, gave informed consent for participation in the study. Exclusion Criteria

- fluoride treatment for osteoporosis within the 2 years before the enrollment date

- bisphosphonate use within the 12 months before the enrollment date

- administration of the following medications within the 6 months before the enrollment

date

- tibolone

- Parathyroid hormone (PTH) (or any derivative)

- systemic glucocorticosteroids (> 5 mg oral prednisone equivalent per day for >

10 days)

- inhaled corticosteroids (> 2000 μg per day for > 10 days)

- anabolic steroids or testosterone

- administration of the following medications within the 3 months before the enrollment

date

- systemic hormone replacement therapy

- selective estrogen receptor modulators

- calcitonin

- calcitriol

- current hyper- or hypothyroidism (allowed if stable on thyroid replacement therapy

and thyroid-stimulating hormone was within the normal range)

- current hyper- or hypoparathyroidism

- albumin-adjusted serum calcium < 8. 5 mg/dL (< 2. 125 mol/L)

- osteomalacia

- rheumatoid arthritis

- Paget's disease

- malignancy within the 5 years before enrollment (except cervical carcinoma in situ or

basal cell carcinoma, which were acceptable)

- renal disease; ie, creatinine clearance ≤ 35 mL/min

- any bone disease, other than osteoporosis, which could interfere with the

interpretation of the findings (eg, osteogenesis imperfecta or osteopetrosis)

- malabsorption syndrome

- weight, height, or girth that could preclude accurate DXA measurements

- < 2 lumbar vertebrae (L1 through L4) evaluable by DXA

- recent long bone fracture (within 6 months)

- osteoporotic-related fracture (ie, crush or wedge vertebral fracture or hip fracture)

known or suspected to have occurred within 2 years of randomization

- > 1 single, grade 1 vertebral fracture

- currently enrolled in or had participated within the previous 30 days in other

investigational device or drug trial(s) (For some trials, this may have been allowed after discussion and written approval from Amgen.)

- known sensitivity to mammalian-derived drug preparations (eg, Herceptin®)

- any organic or psychiatric disorder, serum chemistry, or hematology that, in the

opinion of the investigator, could have prevented the subject from completing the study or have interfered with the interpretation of the study results

- self-reported alcohol or drug abuse within the previous 12 months

- any disorder that compromised the ability to give truly informed consent for

participation in the study

- previous administration of denosumab

- known sensitivity or contraindication to alendronate

- known sensitivity or contraindication to tetracycline derivatives (subjects in the

biopsy substudy only).

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: May 2002
Last updated: September 6, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017