Comparison of the Effects of Teriparatide with those of Risedronate on Lumbar Spine Volumetric Bone Mineral Density in Glucocorticoid-Induced Osteoporosis in Men - ND
- Conditions
- treatment males with glucocorticoid-induced osteoporosis GIOPMedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis
- Registration Number
- EUCTR2006-006315-68-IT
- Lead Sponsor
- Eli Lilly and Company
- 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 , 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 rare exceptions may be enrolled if previously approved A minimum of 2 lumbar vertebrae in the L-1 through L-3 region must be evaluable by quantitative computerized tomography. Normal or clinically insignificant abnormal laboratory values including serum calcium, PTH 1 84 , and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity
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 height reduction 20 either at T-12 or L-1 are eligible for the study see section 6.1.2.2 . 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 patients 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. Normal thyroid function may be documented by a normal serum thyroid-stimulating hormone TSH value during the screening phase or a combination of clinical and biochemical parameters which, in the judgment of the investigator and the Lilly clinical research physician, sufficiently establishes the presence of normal thyroid function. Significantly impaired renal function as defined by measured or calculated endogenous creatinine clearance 30 mL/min using the Cockcroft-Gault formula for creatinine clearance. History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator. Poor medical condition or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator. History of bone marrow or solid organ transplantation. Treatment with any other drug except corticosteroids in the 6 months prior to Visit 2, if that drug is believed by the investigator to significantly affect bone or calcium metabolism. Treatment with - Fluoride at therapeutic doses 20 mg/day for more than 3 months in the 2 years prior to Visit 2, or for more than a total of 2 years, or at any dosages within the 6 months prior to Visit 2. Previous or current use of fluoridated water or topical dental fluoride treatment is permitted - Strontium ranelate for any duration - Intravenous bisphosphonates, at any dose, within the 12 months prior to Visit 2. Previous treatment for any duration with calcitonin, oral bisphosphonates or active vitamin D3 analogues is allowed, but it should be stopped by the randomization visit. Have received treatment within the last 30 days with a drug not including study drug that has not received regulatory approval for any indication at the time of study entry. Known allergy to teriparatide or risedronate, any diluents or excipients of teriparatide, or to any other form of PTH or PTH analog. Presence of any condition which contraindicates 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