Osteopenic and Osteoporotic postmenopausal women MedDRA version: 8.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Trade Name: Forsteo
Product Name: Forsteo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: teriparatide
Other descriptive name: Forsteo
Concentration unit: µg microgram(s)
Concentratio
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Female subjects more than 55 years of age inclusive. 2) Post menopausal status according to the following guidelines: -Cessation of menses for >5 years Or documented bilateral oophorectomy at least 1 year previously -Cessation of menses for 55 and 30 IU/l (confirmed prior to dosing) 3) Diagnosis of osteoporosis or osteopenia with a Bone Mineral Density T score = -1 at the Lumbar spine or total hip. 4) Normocalcemia Serum Calcium =2.0 mmol/l and =2.5mmol/l. 5) Vitamin D 25-(OH) Serum level of = 15ng/ml. 6)Otherwise in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, standard laboratory tests and urinalysis at screening, and the opinion of the investigator. 7) Screening BMI must be >18.5 and =28 and subjects must weigh at least 50 kg to participate in this study. 8) At screening and baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least 3 mins and again when required after 3 mins in the standing position. 9) Able to communicate well with the investigator to understand and comply with the requirements of the study. Understand and sign the written informed consent. 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: 1) Subjects who are using or have used in the past 12 months any of the following medications: strontium ranelate, bisphosphonate (no bisphosphonate use permitted in last 24 months), PTH, Oestrogens, HRT including SERMs, Calcitonin, aluminium supplements. 2) Subjects with a history of chronic use of systemic corticosteroids (oral or i.v.) within the last year where the total dose exceeds 750 mg of oral prednisone or equivalent: NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articular) more than one month prior to screening are NOT exclusionary. 3) Subjects who are using or have used in the past 3 months any of the following medications: Statins, Thiazide Diuretics, ß-blockers, diphenylhydantoin or other anticonvulsants and heparin. 4) Subjects with cancer of history of malignancy of any organ system, treated or untreated, at anytime, whether or not there is evidence of local recurrence or metastases. Some exceptions described in the protocol will apply. 5) Subjects with any of the following: - a +ve HBsAg or Hep C test result. - history og immunodeficiency diseases, inclu a +ve HIV test result. - clinically significant abnornmal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. - clinically significant abnormal creatinine or BUN values or abnormal urinary constituents. - evidence of urinary obstruction or difficultly in voiding at screening. 6) Patients with 25- (OH) Vit D levels less than 15 ng/mL prior to randomisation. 7) subjects with metabolic bone disease, such as paget's disease, crushing syndrome, acromegaly, osteogenesis imperfecta, or serious illness affecting normal bone homeostasis (by history and physical) 8) Subjects exhibing or with a history of any of the following signs and symptoms, - high caffeine intake, vertebral tenderness, surgical scar on neck suggestive of prior thyroid surgery, Rachitic rosary or any bone deformities suggestive or prior rickets, Cafe au lait spots, neuromuscualar irritability. 9) Subjects with measured abnormal safety laboratory values. 10) Subjects with anorexia nervosa, suspected bulemia, or obvious malnutrition. 11) History of drug or alcohol abuse within 12 months prior to dosing. 12) Smokers - more than 20 cigarettes per day used. 13) Subjects who have started Vit D or calcium supplements less than 1 month prior to screening. 14) Participation in any clinical investigation within 4 weeks prior to dosing or longer if required. 15) Blood donors or loss of 400ml or more of blood within 8weeks prior to screening. 16) Significant illness within 2 weeks prior to dosing. 17) History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). 18) History of clinically significant drug allergy or hostory of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the early (Week 1 to Week 4) bone formation and bone resorption biomarker response profiles of a bone anabolic treatment.;Secondary Objective: 1) To describe the early bone formation biomarker response to a bone anabolic reference treatment. 2) To describe the early bone resorption biomarker response to a bone anabolic reference treatment. 3) To describe the early calcium metabolism biomarker response to a bone anabolic reference treatment. 4) To identify appropriate biomarkers for potential use as surrogates of positive bone response during the first weeks of treatment initiation.;Primary end point(s): To Determine the Early (week 1 to Week 4) bone formation and bone resorption biomarker response profiles of a bone anabolic treatment | — |
Countries
United Kingdom
Outcome results
None listed