A six month randomized, double-blind, placebo controlled study across centres in India to study the safety and efficacy of Denosumab in post menopausal women with osteoporosis
- Conditions
- Health Condition 1: null- Post-Menopausal Osteoporosis
- Registration Number
- CTRI/2011/12/002257
- Lead Sponsor
- GlaxoSmithKline Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
1. Subject is willing and able to provide written informed consent.
2. Of Indian origin â?? defined as a person having origins from the Indian subcontinent
(India, Pakistan, Bangladesh and Sri Lanka).
3. Ambulatory woman between the age of 55and 75 years, inclusive.
4. The subject has a BMD absolute value consistent with a T-score < -2.5 and > -4.0 at
either the lumbar spine or total hip. [Table 2 provides BMD equivalents by T-score
thresholds for each DXA scanner manufacturer. The BMD equivalent for
corresponding T-score must be < -2.5 and > -4.0 for a subject to be eligible].
5. Postmenopausal defined as >5-years postmenopausal, which can be >5-years of
spontaneous amenorrhea or >5-years post surgical bilateral oophorectomy. Use
follicle stimulating hormone (FSH) levels > 40 mIU/mL to confirm surgical
postmenopausal status, where bilateral oophorectomy status is uncertain.
Previous or Current Medical Conditions:
1. Bone/metabolic disease:
a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,
which may interfere with the interpretation of the findings.
b. Pagetâ??s disease
c. Cushingâ??s disease
d. Hyperprolactinemia
2. Current hyperparathyroidism or hypoparathyroidism
3. Thyroid condition: Hyper- or hypothyroidism; however, subjects on stable thyroid
hormone replacement therapy may be allowed per the following criteria:
a. If TSH level is below normal range, subject is not eligible for the study.
b. If TSH level is elevated ( 5.5 μIU/mL to 10.0 μIU/mL), serum T4 should be
measured.
• If serum T4 is within normal range, subject is eligible.
• If serum T4 is outside of normal range, subject is not eligible for the study.
c. If TSH level is above 10.0 μIU/mL, subject is not eligible.
4. Rheumatoid arthritis
5. Malignancy:
a. Malignancy (except fully resected cutaneous basal cell or squamous cell
carcinoma, cervical or breast ductal carcinoma in situ) within the last 5-years.
6. Malabsorption syndrome: malabsorption syndrome or any gastrointestinal
disorders associated with malabsorption.
7. Liver disease:
a. Cirrhosis of the liver
b. Unstable liver disease (as defined by the presence of ascites, encephalopathy,
coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent
jaundice), known biliary abnormalities (with the exception of Gilbertâ??s
syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are
acceptable, if subject otherwise meet study entry criteria (e.g., presence of
hepatitis B surface antigen or positive Hepatitis C test result within 3-months of
Screening).
8. Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last
12-months which the Investigator believes would interfere with understanding or
completing the study.
9. Biological abnormalities:
a. Any disorder that compromises the ability of the subject to give written
informed consent or to comply with study procedures.
b. 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.
c. Known to have tested positive for human immunodeficiency virus (HIV).
10. Vitamin D deficiency: Vitamin D deficiency (25-(OH) vitamin D level
20 ng/mL). Vitamin D repletion will be permitted and subjects may be re-tested
with 25-(OH) vitamin D.
11. Oral/Dental Conditions
a. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
b. Active dental or jaw condition which requires oral surgery.
c. Planned invasive dental procedure.
d. Non-healed dental or oral surgery.
Concomitant Medications:
12. Previous strontium or IV bisphosphonate: Administration of intravenous (IV)
bisphosphonate, fluoride, or strontium for osteoporosis within the last 5-years.
13. Oral bisphosphonate: Oral bisphosphonate treatment for osteoporosis:
a. If used for >=3-years cumulatively, subject is ineligible.
b. If used for 3-months but 3-years cumulatively:
• If the last dose w
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess between the denosumab and placebo treatment groups:Percent change in BMD at the lumbar spine from Baseline to Month 6Timepoint: To assess between the denosumab and placebo treatment groups:Percent change in BMD at the lumbar spine from Baseline to Month 6
- Secondary Outcome Measures
Name Time Method To assess between the denosumab and placebo treatment groups:Percent change in BMD at the femoral neck and trochanter from Baseline to Month <br/ ><br>6.Timepoint: 6 month;To assess between the denosumab and placebo treatment groups:Percent change in BMD at the total hip from Baseline to Month 6.Timepoint: 6 month;To assess between the denosumab and placebo treatment groupsPercent change in serum CTX and P1NP from Baseline to Months 1, 3 and 6.Timepoint: Month 1,3 and 6