An open-label, international, multi center, parallel group, phase IIIb, randomised trial investigating lumbar spine Bone Mineral Density (BMD) changes in postmenopausal women with primary osteoporosis initially treated with 12 months of full lentght parathyroid hormone (PTH 1-84)followed by 12 months of treatment with risedronate followed by either 12 months treatment with PHT (1-84) or risedronate
- Conditions
- post-menopausal women with osteoporosisMedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2005-000730-20-IT
- Lead Sponsor
- TAKEDA PHARMA A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 390
1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject above 50 years old? 3. Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator? 4. Does the subject have primary osteoporosis with a lumbar spine T score equal to or less than -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)? 5. Does the subject have a life expectancy of >3 years? 6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)? Bone biopsy sub trial: 7. Has the subject given consent to having a bone biopsy performed? 8. Has the subject completed trial period II in FP-001-IM?Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
1.Is the subject currently in treatment with Selective Estrogen Receptor Modulators (SERMs) (e.g.raloxifen)? If the SERM treatment is terminated the subject can still be evaluated for eligibility.2.Has the subject ever been treated with any bisphosphonate other than alendronate or risedronate? 3.Has the subject been treated with alendronate or risedronate for more than 3 years in total? 4.Has the subject during lifetime been treated with both alendronate and risedronate, including sequential treatment? 5.Has the subject during lifetime been treated with strontium > 3 months in total? 6.Has the subject during lifetime been treated with fluoride > 3 months in total? 7.Has the subject during lifetime been treated with teriparatide or PTH (1-84)? 8.Has the subject during lifetime been treated with calcitonin during the last 3 months? 9.Is the subject currently receiving antiepileptic medication? 10.Does the subject take any other medication, that according to investigator`s opinion, is known to affect bone metabolism? 11.Has the subject received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: `5.0mg prednisolon or equivalent daily for 3 months during the last year or `2.5mg prednisolon or equivalent daily for 6 months during the last year 12.Has the subject ever received radiation therapy to the skeleton? 13.Has the subject been treated for cancer (other than basocellular skin cancer) within the last 5 years? 14.Has the subject ever had malignant disease affecting the skeleton? 15.Has the subject ever had breast cancer? 16.Does the subject have any known clinically significant diseases affecting calcium metabolism? 17.Does the subject have any known history of metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, Paget`s disease, osteogenesis imperfecta, or osteomalacia)? 18.Does the subject have a medical history of abnormalities in oesophagus prohibiting emptying of oesophagus (e.g.achalasia or stricture) and inability to ingest risedronate (should be able to take risedronate upright) judged by the investigator to be significant? 19.Does the subject have any known history of hypersensitivity to parathyroid hormone or risedronate or any of the excipients in the products? 20.Does the subject have any clinically significant conduction abnormalities e.g.second degree atrial ventricular block as assessed by the investigator based on ECG reading? 21.Does the subject have a plasma 25-hydroxyvitamin D level <9.2ng/ml after at least 14 days of calcium and vitamin D supplementation? 22.Does the subject have a plasma PTH of > 65pg/ml and a total serum calcium value >2.49 mmol/l? 23.Does the subject have hypercalcaemia (total serum calcium value >2.55mmol/l) after at least 14 days of calcium supplementation? 24.Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator? 25.Does the subject have impaired kidney function with creatinine clearance <30ml/min (indirect measurement by serum creatinine)? 26.Does the subject have a 24 hours urinary calcium > 360mg after at least 14 days of calcium supplementation? 27.Has the subject ever shown intolerance to any bisphosphonate? 28.Is the subject scheduled for vertebroplasty? 29.Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days or does the subject plan to participate in such within the next 3 y
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