E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fracture of distal radius (Colles’) fracture |
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MedDRA Classification |
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 compare the effect of 8 weeks of subcutaneous treatment with teriparatide 20 or 40 µg/day versus placebo on time to radiographic fracture healing, (defined by cortical bridging) in postmenopausal women with a unilateral, dorsally angulated, distal radius (Colles’) fracture.
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E.2.2 | Secondary objectives of the trial |
Radiologic: .Time to early endosteal healing as evidenced by radiographs .Time to early endosteal healing as evidenced by CT scan .Time to partial endosteal healing as evidenced by radiographs .Time to partial endosteal healing as evidenced by CT scan .Time to trabecular union as evidenced by radiographs .Time to trabecular union as evidenced by CT scan .Time to cortical bridging as evidenced by CT scan .Evaluation of anatomical deformity as evidenced by radiographs. Functional/Clinical: .Assessment of pain and hand function via the self-administered Patient-Rated Wrist Evaluation .Assessment of disability of the arm, shoulder, and hand via the self-administered DASH outcome measure. .Assessment of grip strength via a JAMAR dynamometer. .Assessment of wrist ROM .A Mayo wrist score calculated from other functional assessments. Safety: .Assessment of vital signs, clinical laboratory tests, and reports of adverse events.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Most important inclusion criteria: -Ambulatory, postmenopausal, women 45 to 80 years of age. Postmenopausal is defined as at least 2 years without regular menses. -Sustained a unilateral, dorsally angulated fracture of the distal radius within past one week. -Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint or brace). -Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator. - Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study. -In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily 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 |
- No restrictions on concomitant medications after study endpoint, Visit 11 except for oral strontium renalate and flouride. - 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. - History of a malignant neoplasm in the 5 years prior to Visit 2, 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. -Have currently known, suspected, or history of other diseases that: ·affect bone metabolism, other than postmenopausal osteoporosis ·cause secondary osteoporosis that has been clinically active in the 1 year prior to Visit 2. - Have elevated serum calcium values based on local laboratory reference ranges. - Active liver disease (liver enzymes more than three times the upper limit of normal) or clinical jaundice. - History of symptomatic nephro- or urolithiasis in the 2 years prior to Visit 2. -Previous fractures or bone surgery in the currently fractured distal forearm. - Joint diseases such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm. - Requirement for chronic treatment with nonsteroidal antiinflammatory drugs (NSAIDs, including Cox-2 inhibitors), defined as more than 3 consecutive months of any NSAID treatment. Dosages of aspirin for coronary heart disease prophylaxis £500 mg/day is acceptable. Patients may take NSAIDs after study endpoint (Week 17). Short-term use of NSAIDs for pain management is acceptable. - Treatment with: ·oral bisphosphonates for more than 2 consecutive months in the last 1 year, or have received any oral or intravenous bisphosphonate therapy within the last 6 months prior to screening. Patients may take bisphosphonates after study endpoint (Week 17). ·oral strontium renalate for any duration. ·systemic corticosteroids (other than for adrenal replacement therapy) for more than 30 days (total) in the 6 months prior to Visit 2, or any systemic corticosteroid dose in the 1 month prior to Visit 2. Ophthalmic, otic, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions. Orally inhaled glucocortocsteriods will not exceed a daily dose of 800 mg of beclomethasone. Patients may take systemic corticosteriods after study endpoint (Week 17). ·fluoride at therapeutic doses (³20 mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to Visit 2 (previous or current use of fluoridated water or topical dental fluoride treatment is permitted). ·androgen or other anabolic steroids more recently than 6 months prior to Visit 2. Patients may take androgens or other anabolic steriods after study endpoint (Week 17). - 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 or psychiatric condition for treatment with an investigational drug, in the opinion of the investigator. - Have a known allergy to teriparatide, any diluents or excipients of teriparatide, or to any other form of PTH or PTH analog. - Have received treatment within the previous 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. - Participation in any other clinical study studying teriparatide or have received prior treatment with PTH or a PTH fragment or analog. - Patients are not permitted to join any clinical studies involving drugs or indications not approved by the FDA at any time during their participation in the distal radius fracture study. - Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. - Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Lilly employees may participate in Lilly sponsored clinical studies, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. - Evidence of severe renal insuficiency, in the opinion of investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is the time to a radiographically healed fracture. This is defined as the interval, in days, between the occurrence of the fracture and the time when bridging of the four cortices is determined by x-ray film. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |