Osteoporosis
Conditions
Interventions
Trade Name: Forsteo
Product Name: Teriparatide
Product Code: LY333334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Teriparatide
Current Sponsor code: LY333334
Concentration unit: µ
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Ambulatory, postmenopausal women aged 45 to 90 years inclusive at the time of entry into the trial, whose last menstrual period or bilateral oophorectomy occurred at least 5 years prior to entry into the trial. Women below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum FSH level =30 IU/L and serum estradiol level =20 pg/ml or =73 pmol/L. [2] Free of severe or chronically disabling conditions other than osteoporosis. [3] Able to use a pen-type injection delivery system satisfactorily in the opinion of the investigator and willing to be trained on and use the pen-injector on a daily basis. [4] Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study. [5] Posterior-anterior lumbar spine (L-1 through L-4) BMD and/or femoral neck BMD and/or total hip BMD measurement at least 2.5 standard deviations (SD) below the average bone mass for young women (T-score equal or below to -2.5 standard deviations). The lumbar spine and hip BMD assessment and the determination of the patient’s eligibility for entry into the screening phase will be made by the individual investigator. Any lumbar vertebra that cannot be analyzed due to artifacts, severe crush fracture, osteophytes, or other abnormalities, should be excluded from the analysis. A minimum of two lumbar vertebrae in the L-1 through L-4 region must be evaluable by DXA if this is the only anatomical site where the BMD cut-off level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [7]History of unresolved skeletal diseases that affect bone metabolism other than postmenopausal osteoporosis including Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption. [8]In the opinion of the investigator, have any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure (for example, coagulation abnormality, anticoagulant medication, extreme obesity, etc). [9]Have undergone two previous transiliac bone biopsies (one in each iliac crest). Patients with one previous transiliac bone biopsy are eligible provided that the new sample is obtained from the contralateral iliac crest. [10]History of malignant neoplasms in the 5 years prior to Visit 1, 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 be randomized. [11]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, i.e. prior external beam or implant radiation therapy. As an elevation of serum skeletal alkaline phosphatase activity may indicate the presence of Paget’s disease, an unexplained elevation of this enzyme activity will also be exclusionary. [12]Abnormal thyroid function not corrected by therapy. Normal thyroid function may be documented by a normal TSH during the screening phase or a combination of clinical and biochemical parameters which, in the judgment of the investigator and the Lilly Clinical Research Physician, sufficiently establishes the presence of normal thyroid function. [13]Active liver disease or clinical jaundice. [14]Significantly impaired renal function as defined by either of the following criteria:Serum creatinine that, in the opinion of the investigator, indicates significant renal impairment / Measured or calculated endogenous creatinine clearance 50,000 IU/week, or with any dose of calcitriol or Vitamin D analogs or agonists in the 6 months prior to Visit 2. [20]Treatment with systemic corticosteroids in the last month prior to Vi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the bone formation activity, measured by the mineralization surface (MS%BS), in iliac crest bone biopsies from postmenopausal women with osteoporosis following 6 months of treatment with teriparatide 20 µg/day plus elemental calcium and Vitamin D, to that following strontium ranelate 2 g/day plus elemental calcium and Vitamin D. ;Secondary Objective: ·Other dynamic histomorphometric parameters of bone formation and resorption. ·Structural (static) parameters of cortical and trabecular bone. ·Biochemical markers of bone turnover including markers of bone formation: serum aminoterminal propeptide of type I procollagen [P1NP], bone-specific alkaline phosphatase [BSAP], and bone resorption: serum type I collagen degradation fragments (ß-CTx). ·Safety as determined by absence of primary mineralization defects, woven bone, and other histological anomalies, and other histological anomalies, and clinical adverse events reports. An additional exploratory objective of this study will be: ·To examine the relationship between biochemical markers at 1, 3 and 6 months and the histomorphometric parameters following 6 months of therapy with teriparatide or strontium ranelate. ;Primary end point(s): The primary efficacy end point is measurement of Mineralization surface (MS%BS) evaluated in double tetracycline stained bone biopsies. Mineralization surface (MS%BS) reflects the percentage of cancellous surface that is being actively mineralized, i.e. the proportion of the cancellous surface covered by newly formed osteoid. The most accurate calculation of MS%BS is dividing the area of double-label surfaces plus one-half the area of single-label surfaces by the total bone surface area. | — |
Countries
Czech Republic, Germany, Spain
Outcome results
None listed