Osteoporosis MedDRA version: 12.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Trade Name: Forsteo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Teriparatide
Concentration unit: µg/µl microgram(s)/microlitre
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must: - Have a BMD T-score (at the lumbar spine or total hip) of less than or equal to -2.5 - Be female - Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but 50 nmol/L (after vitamin D3 loading) 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: Patients will not be admitted to the study if they exhibit any of the following: - Evidence of a clinically significant organic disease which could prevent the patient from completing the study - A BMI less than 18 or greater than 35 - Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers) - Any history of cancer within the past 5 years excluding skin cancer non melanomas - Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget’s disease of bone - Chronic renal disease (as defined by an estimated glomerular filtration rate of = 30mL/min) - Acute or chronic hepatic disease - Malabsorption syndromes - Hyperthyroidism as manifested by TSH outside the lower limit of the normal range - Hyperparathyroidism - Hypocalcemia or hypercalcemia - Osteomalacia - Cushing’s syndrome - Current use of glucocorticoid therapy - A corrected serum calcium less than 2.2 mmol/L and a PTH above 100ng/L (that persists after testing and treatment for vitamin D deficiency) - A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck - Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator - Any previous use of bisphosphonate - Use any of the following medications within 12 months of starting study drug - Any fluoride with the exception of use for oral hygiene - Strontium Ranelate - Other bone agents (e.g. SERM, isoflavones, HRT) - Participation in another clinical trial involving active therapy 3 months prior to enrolment - Less than 5 years since menopause - Bilateral fractures in the measurement regions (hip, tibia and forearm). - Recent fracture within the last 12 months - Prior radiation therapy which may involve the skeleton - Hypersensitivity to teriparatide or any of its exipients - Unexplained elevations of alkaline phosphatase - Any known contraindication to the use of teriparatide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. What is the effect of teriparatide on the axial and appendicular skeleton and on cortical and trabecular bone as assessed by QCT? 2. What are the time course and the magnitude of effect of teriparatide on biochemical markers of bone turnover? ; Secondary Objective: 1. Does the 12 week HR-pQCT response to teriparatide predict the BMD response at 104 weeks? 2. Do the early changes in biochemical markers of bone turnover predict the BMD response to teriparatide at 52 and 104 weeks? ;Primary end point(s): Change in volumetric BMD of the spine by QCT (vertebrae L1-3) at 104 weeks. | — |
Countries
United Kingdom
Outcome results
None listed