Males with glucocorticoid-induced osteoporosis
Conditions
Interventions
Trade Name: Forsteo
Product Name: Teriparatide
Product Code: LY333334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: teriparatide
Concentration unit: µg/ml microgram(s)/millilitre
Co
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that teriparatide 20 µg subcutaneously once daily is superior to risedronate 35 mg orally once weekly in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density in males with glucocorticoid-induced osteoporosis. All patients will receive elemental calcium 1000 mg orally once daily and vitamin D 800-1200 IU orally once daily.;Secondary Objective: To test the hypothesis that teriparatide is superior to risedronate in the improvement of: - Lumbar spine volumetric trabecular BMD, as measured by QCT, at 6 months of treatment. - Lumbar spine volumetric integral BMD, as measured by QCT, at 6 and 18 months of treatment. - Three-dimensional microstructural variables, as measured by HR-QCT in T-12, at 6 and 18 months of treatment. - Biomechanical variables evaluated by a finite element analysis in the 12th thoracic vertebra (T-12), at 6 and 18 months of treatment. To compare the effects of teriparatide with those of risedronate on: - Areal BMD response at the lumbar spine, femoral neck, and total hip, at 18 months of treatment. - Biochemical markers of bone turnover including [P1NP] and [ß-CTx], at 3, 6 months and 18 months of treatment. To evaluate safety. ;Primary end point(s): Change in actual lumbar spine volumetric trabecular BMD from baseline to 18 months, determined by quantitative computerized tomography. | — |
Countries
Germany, Greece, Italy, Spain
Outcome results
None listed