E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal Women and Men with Low Bone Mass and a Recent Pertrochanteric Fracture |
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E.1.1.1 | Medical condition in easily understood language |
Postmenopausal Women and Men with Low Bone Mass and a Recent Hip Fracture |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031288 |
E.1.2 | Term | Osteoporosis with fracture |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal 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. 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in lumbar spine BMD |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to 18 months of treatment |
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E.5.2 | Secondary end point(s) |
•Change in lumbar spine areal BMD [Time Frame: From baseline to 26 weeks and 12 months of treatment]
•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]
•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]
•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]
•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]
•To evaluate safety [Time Frame: At all timepoints]
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
See above, for each secondary endpoint |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
6 months, double dummy, 6 to 18 months open label |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Canada |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Ireland |
Italy |
Mexico |
Norway |
Spain |
Sweden |
United Kingdom |
United States |
Croatia |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 3 |