Comparison of Teriparatide with Risedronate on Lumbar Spine Bone Mineral Density in Men and Postmenopausal Women with Low Bone Mass and a Recent Pertrochanteric Hip Fracture
- Conditions
- Postmenopausal Women and Men with Low Bone Mass and a Recent Pertrochanteric FractureMedDRA version: 17.1Level: LLTClassification code 10031288Term: Osteoporosis with fractureSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2008-002693-35-CZ
- Lead Sponsor
- Eli Lilly and Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Men and postmenopausal women aged 50 years old or more at the time of entry into the trial. In women, last menstrual period or bilateral oophorectomy has to occur at least 2 years prior to entry into the trial. Patients must be ambulatory prior to the fracture, and free of severe or chronically disabling conditions, including dementia and gait problems and have a life expectancy of at least 3 years.
Patient has sustained a unilateral, fracture of the trochanteric region caused by a low-energy injury. Fracture is treated with an intramedular hip nail or a sliding compression hip screw with or without a trochanteric stabilizing plate. Able to satisfactorily use a pen-type injection delivery system in the opinion of the investigator and willing to be trained on use of the pen-injector and willing to use the pen-injector on a daily basis, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector.
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
Clinically significant abnormal laboratory values (as defined by the investigator) of total alkaline phosphatase and/or abnormally elevated serum total calcium levels at the screening visit. Abnormally elevated values of serum intact PTH(1 84) at the screening visit. Severe vitamin D deficiency. Abnormally elevated values of fT4 at the screening visit. History of unresolved skeletal diseases that affect bone metabolism including renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption. Increased baseline risk of osteosarcoma. 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 a malignant neoplasm in the 5 years prior to Visit 1, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study. History of symptomatic nephro- or urolithiasis in the year prior to Visit 1. Active liver disease or clinical jaundice. Significantly impaired renal function. History of bone marrow or solid organ transplantation. Bilateral hip fractures. Previous fracture(s) or bone surgery in the currently fractured hip. Soft tissue infection at the operation site. Patient treated with hip prosthetic replacement techniques. Patient treated with external fixation of the petrochantic fracture. Patient treated with bone grafting or osteotomies. Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants or with non-invasive interventiones with ultrasound, magnetic field/electrical stimulation. Treatment with IV/oral bisphosphonats, SERM, calcitonin, estrogen antagonists, tibolone, denosumab. Prior treatment with PTH, teriparatide or risedronate or excipients of teriparatide or to any other form of PTH or PTH analogue. 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 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 BMD in postmenopausal women and men with low bone mass and a recent pertrochanteric hip fracture, as measured by dual energy x-ray absorptiometry.;Secondary Objective: Superiority to risedronate in the change from baseline in lumbar spine areal BMD measured by areal DXA, at 26 weeks and 12 months of treatment. Effects of teriparatide with those of risedronate on patient self-reported physical function and health status. Effects of teriparatide with those of risedronate on patient functional activities. Evaluate safety.;Primary end point(s): Change in lumbar spine BMD;Timepoint(s) of evaluation of this end point: From baseline to 18 months of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Change in lumbar spine areal BMD [Time Frame: From baseline to 26 weeks and 12 months of treatment] <br>•Change in areal BMD measured at the femoral neck and total hip of the non-fractured limb [Time Frame: From baseline to 26 weeks, 12 months and 18 months of treatment] <br>•of teriparatide with those of risedronate on patient self-reported physical function and health status [Time Frame: From baseline to 6, 12, 18, and 26 weeks of treatment] <br>•To compare the effects of teriparatide with those of risedronate on patient self-reported pain at the hip [Time Frame: From baseline to 6, 12, 18, and 26 weeks of treatment] <br>•To compare the effects of teriparatide with those of risedronate on patient functional activities [Time Frame: From baseline to 6, 12, 18, and 26 weeks of treatment] <br>•To evaluate safety [Time Frame: At all timepoints]<br> ;Timepoint(s) of evaluation of this end point: See above, for each secondary endpoint