Clinical trial NCT01465568: Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
Official title: Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: osteoporosis
denosumab
RANKL
glucocorticoids
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2011-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.

Detailed description: There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).

Eligibility criteria: Inclusion Criteria:

1. Women or adult men (\>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.
2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.
3. Having received oral bisphosphonate treatment for at least 2 years.
4. Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores \< -2.5 or Z scores \< -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.
5. Informed consent from patients.

Exclusion Criteria:

1. Patients with previous use of denosumab or teriparatide.
2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.
3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
4. Patients with unexplained hypocalcemia.
5. Patients with serum creatinine level of \>=200umol/L.

Primary outcomes:
measure: bone mineral density (BMD) changes at the lumbar spine
timeFrame: baseline, 6 months and 12 months
Secondary outcomes:
measure: BMD changes in the total hip and femoral neck
timeFrame: baseline, 6 months and 12 months
measure: bone turnover markers
timeFrame: baseline, 6 months and 12 months
measure: New vertebral fractures
timeFrame: 12 months
measure: adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Tuen Mun Hospital
name: Chi Chiu Mok, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mok CC, Ho LY, Ma KM. Switching of oral bisphosphonates to denosumab in chronic glucocorticoid users: a 12-month randomized controlled trial. Bone. 2015 Jun;75:222-8. doi: 10.1016/j.bone.2015.03.002. Epub 2015 Mar 8.