Postmenopausal Women and Men with Low Bone Mass and a Recent Pertrochanteric Fracture MedDRA version: 17.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Forsteo
Product Name: teriparatide
Product Code: LY333334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TERIPARATIDE
CAS Number: 52232674
Current Sponsor code: GHDK
Othe
Sponsors
Eli Lilly and Company Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and postmenopausal women aged =50 years inclusive 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. Subjects must be able to walk unassisted prior to the fracture, and free of severe or chronically disabling conditions, including dementia and gait problems. Have a life expectancy of at least 3 years. AP lumbar spine (L-1 through L-4) BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs below the average bone mass for young women and men. 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
Exclusion criteria
Exclusion criteria: 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 defined at 25-hydroxy-vitamin D levels. Abnormally elevated values of fT4 at the screening visit. Patients with sub-clinical hyperthyroidism, defined as abnormally low serum values of TSH with normal fT4 values, are eligible to participate in the study. 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; 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 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 or with ordinary Ender nails or 2D bent nails. 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 fluoride, stontium ranelate, IV/oral bisphosphonates, SERM, calcitonin, estrogen antagonists, tibolone. 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.
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 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 areal BMD measured by areal DXA at the femoral neck and total hip of the non-fractured limb, at 12 and 18 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 self-reported pain at the hip at 6, 12, 18 and 26 weeks from randomisation. Effects of teriparatide with those of risedronate on patient functional activities. Evaluate safety.;Primary end point(s): change in actual AP lumbar spine BMD as detected by areal DXA from baseline to 18 months | — |
Countries
Austria, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden, United Kingdom
Contacts
Public ContactVirginia Ann Wood
Eli Lilly and Company Ltd
Outcome results
None listed