Oesteoporosis
Conditions
Interventions
Trade Name: Forsteo
Product Name: Forsteo
Product Code: LY333334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Teripa
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Ambulatory, postmenopausal women. [2] Aged 55 to 85 years, inclusive. [3] Free of severe or chronically disabling conditions other than osteoporosis. [4] Without language barrier, cooperative, expected to return for all follow-up visits, and who give informed consent before entering the study and after being informed of the medications and procedures to be used in this study. [5] A minimum of either one moderate or two mild atraumatic vertebral fractures • Atraumatic is defined as not caused by wound or injury that is severe enough to cause a fracture in otherwise healthy persons. • Subjects with a history of traumatic fractures (for example, those caused by automobile accidents or falls from greater than standing height) are eligible only if they also have a minimum of one moderate or two mild atraumatic vertebral fractures and a minimum of seven evaluable nonfractured vertebrae. • The initial fracture assessment and the determination of eligibility of the subject to be entered into the study will be made by the individual investigator. [6] Total hip BMD or lumbar spine (L-1 to L-4) BMD measurement more than 2.5 standard deviations below the average bone mass for young, healthy women (T-score), as determined from the manufacturer’s database, only in subjects with fewer than two moderate fractures. [7] Normal or clinically nonsignificant abnormal laboratory values (serum calcium, 25-hydroxyvitamin D, TSH, and urine calcium must be within normal limits at enrollment). 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: [8] Fractures in areas of bone affected by diseases other than osteoporosis. [9] Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained. [10] Current or recent metabolic bone disorders other than postmenopausal osteoporosis or disease which affects bone metabolism. [12] History of carcinoma in the previous 5 yrs or currently suspected carcinoma, with the exception of excised superficial lessions. [13] Nephrolithiasis or urolithiasis in the 2 yrs prior to enrollment. Subjects with any history of nephro- or urolithiasis must have an appropriate radiology study within 6 calendar months prior to enrollment to document the absence of active disease. [14] Current or recent sprue, inflammatory bowel disease, or malabsorption syndrome. [15] Significantly impaired hepatic function or renal function. [19] Treatment with androgens or other anabolic steroids in the 6 calendar months prior to enrollment. [20] Treatment with calcitonins in the 2 calendar months prior to enrollment. [21] Treatment with estrogen as follows: • oral, transdermal, or injectable estrogens, estrogen analogs, estrogen agonists, and estrogen antagonists in the 3 calendar months prior to enrollment, or for more than 2 months in the 12 calendar months prior to enrollment (with exception of oral estriol). • intravaginal estrogens in doses more than 1.25 mg conjugated equine estrogen or 25 µg estradiol for more than two doses per week in the 3 calendar months prior to enrollment (with the exception of estriol). [22] Treatment with progestins or selective estrogen receptor modulators (SERMs) in the 3 calendar months prior to enrollment, or for more than 2 months in the 12 calendar months prior to enrollment. [23] Treatment with corticosteroids as follows: Subjects may not be treated with any of the following in the 3 calendar months prior to enrollment; for more than 30 days in the 12 calendar months prior to enrollment; or for more than 30 days in any 12-calendar- month period following enrollment: • systemic corticosteroids in doses >5 mg prednisone/day orequivalent; • topical corticosteroids under occlusive dressings in doses >0.5 grams of 0.5% triamcinolone/day or equivalent; • topical corticosteroids not under occlusive dressings in doses >3 grams of 0.5% betamethasone/day or equivalent; • orally inhaled or nasally inhaled corticosteroids in doses >400 µg/day beclomethasone or equivalent; or • more than a single injection of intra-articular corticosteroids in doses >40 mg triamcinolone or equivalent. Both preenrollment and postenrollment, ophthalmic and otic corticosteroid therapy may be used without limitation. [24] Treatment with fluorides in the 6 calendar months prior to enrollment or for more than 60 days in the 24 calendar months prior to enrollment. Current use of fluoridated water and topical dental fluoride treatments are permitted. [25] Treatment with oral bisphosphonates in the 3 calendar months prior to enrollment or for more than 60 days in the 24 calendar months prior to enrollment; treatment with intravenous bisphosphonates in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether teriparatide, given as 20 mcg once daily by subcutaneous injection in postmenopausal women with osteoporosis who are at high risk for fracture, will be associated with an increase in skeletal plasma clearance of 99m Technetium methylene diphosphonate ( 99m Tc-MDP) measured from baseline to 18 months in the whole skeleton using nuclear scintigraphy.; Secondary Objective: Determine whether skeletal plasma clearance and skeletal uptake of 99m Tc-MDP measured in the whole skeleton and six subregions (skull, mandible, spine, pelvis, and upper and lower extremities) and quantitative visual score of focal and diffuse changes in the whole skeleton will demonstrate change at the following time points in response to teriparatide therapy: o Increase from baseline to 3 months o Increase from 3 months to 18 months o Increase from baseline to 18 months o Decrease from 18 months to 24 months o Approach baseline value at 24 months • To determine adverse experiences, laboratory variables, and other aspects of subject safety and tolerance of teriparatide. ;Primary end point(s): This is an exploratory study. The primary endpoint in this study is change in whole body skeletal plasma clearance from baseline to 18 months. | — |
Countries
United Kingdom
Outcome results
None listed