Treatment of osteoporosis in postmenopausal women MedDRA version: 13.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: synthetic human parathyroid hormone(1-34)
Product Code: NA
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: teriparatide
CAS Number: 52232-67-4
Current Sponsor code: shPTH(1-3
Sponsors
Elli Lilly and Company
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 85 years inclusive at the time of entry into the trial, whose last menstrual period occurred at least 2 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 follicle stimulating hormone (FSH) level of >30 IU/L and serum estradiol level of =65 years) yes F.1.3.1 Number of subjects for this age range 168
Exclusion criteria
Exclusion criteria: [1] Abnormal laboratory values for albumin and alkaline phosphatase (normal range as defined by the central laboratory), except for clinically insignificant values as determined by the investigator in conjunction with the Lilly physician. [2] Laboratory values outside the ranges for the following: Serum calcium 8.3 -10.6 mg/dL (conventional units) 2.07 - 2.64 mmol/L (SI units) iPTH(1 84)b 11-72 pg/mL (conventional units) 1.2-7.6 pmol/L (SI units) 25 hydroxyvitamin D levels 20 to 61 ng/mL (conventional units) 50-153 pmol/mL (SI units) a Ranges specified for adults =18 years of age. b Range using the Centaur Method. [3] 24-hour urine calcium higher than 300 mg/day. [4] Abnormal thyroid function not corrected by therapy. [5] Significantly impaired renal function. This is defined as: - serum creatinine >2.0 mg/dL or 177 micromol/L; or - measured or calculated creatinine clearance that, in the opinion of the investigator, indicates significant renal impairment. [6] Significantly impaired hepatic function, defined as: • single transaminase (alanine transaminase [ALT], aspartate transaminase [AST], or gamma-glutamyl transpeptidase [GGT]) greater than 3 times the upper limit of normal (ULN); or total bilirubin greater than 2.0 mg/dL (34 micromol/L). [7] History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption. [8] History of malignant neoplasms in the 5 years prior to randomization, [9] History of nephrolithiasis or urolithiasis in the 2 years prior to randomization. [10] Use of a pacemaker. [11] Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia. [12] History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to randomization, in the opinion of the investigator. 31 Prior participation in any other clinical trial studying or prior treatment with denosumab or strontium ranelate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if one or more of the TD-delivered teriparatide doses is not inferior to SQ-delivered teriparatide 20mcg /day based on mean percent change in BMD at 12 months. The primary variable is the percent change from baseline in lumbar spine BMD at 12 months.;Secondary Objective: • Evaluate differences between SQ and each TD dose in lumbar spine BMD at 6 months, as assessed by the Central Reader, Evaluate differences between SQ and each TD and procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide (CTX) . • Evaluate differences between SQ and each TD dose in C terminal propeptide (C1CP; converted to serum procollagen type 1 C propeptide [P1CP] for comparison to previous SQ studies). • Determine the safety of TD-delivered teriparatide for a range of doses. • Evaluate the population PKs of teriparatide and explore the relationship between teriparatide plasma concentrations and PD endpoints. • Evaluate the immunogenic response to TD-administered teriparatide. • Evaluate data collected from patients via questionnaire on ease of use of the TD and SQ delivery experiences. This is a device related outcome This is a device related outcome.;Primary end point(s): The primary variable is the percent change from baseline in lumbar spine BMD at 12 months;Timepoint(s) of evaluation of this end point: at 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluate differences between SQ and each TD dose in lumbar spine BMD at 6 months, as assessed by the Central Reader. • Evaluate differences between SQ and each TD dose in procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide (CTX). • Evaluate differences between SQ and each TD dose in C terminal propeptide (C1CP; converted to serum procollagen type 1 C propeptide [P1CP] for comparison to previous SQ studies). • Determine the safety of TD-delivered teriparatide for a range of doses. • Evaluate the population PK of teriparatide and explore the relationship between teriparatide plasma concentrations and PD endpoints. • Evaluate the immunogenic response to TD-administered teriparatide. • Evaluate data collected from patients via questionnaire on ease of use of the TD and SQ delivery experiences. This is a device-related outcome. ;Timepoint(s) of evaluation of this end point: at 6 months | — |
Countries
Argentina, Estonia, Hungary, Mexico, Romania
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company
Outcome results
None listed