Comparison of the Effects of Teriparatide with those of Risendronate on Lumbar Spine Volumetric Bone Mineral Density in GLucocorticpid-Induced Osteoporosis in Men - GHDH
- Conditions
- Males with glucocorticoid-induced osteoporosis
- Registration Number
- EUCTR2006-006315-68-DE
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 104
- Ambulatory men 25 years of age and older presenting to Visit 1 with a BMD of at least 1.5 SD below the corresponding normal young adult men average BMD (T score of –1.5 or lower), as determined from the manufacturer’s database at any of the following regions of interest: total hip, femoral neck, or lumbar spine.
- Have received glucocorticoid therapy at an average dose of at least 5.0 mg/day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding screening (Visit 1), as determined by medical history.
- A minimum of 2 lumbar vertebrae in the L-1 through L-3 region must be evaluable by QCT.
- Normal or clinically insignificant abnormal lab values.
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
- Presence of a mild, moderate or severe spinal fracture in both T-12 and L-1, as determined by the central reading facility using the semiquantitative technique by Genant et al. (1993). Patients with a normal vertebral body height (i.e.; vertebral heights reduction <20%) either at T-12 or L-1 are eligible for the study
- Abnormal albumin-corrected serum calcium levels as determined by the investigators’ site laboratory.
- History of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis.
- History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated.
- Increased baseline risk of osteosarcoma; this includes subjects with Paget’s disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. As elevation of serum skeletal alkaline phosphatase activity may indicate the presence of Paget’s disease, an unexplained elevation of this enzyme activity will also be exclusionary.
- History of symptomatic nephro- or urolithiasis in the year prior to Visit 2.
- Abnormal thyroid function not corrected by therapy.
- Significantly impaired renal function.
- Treatment with exclusionary therapy described in protocol.
- Presence of any condition which contraindicates teriparatide or risedronate therapy.
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