Effects of Teriparatide Injection for the Treatment of Men and Women with Osteoporosis Associated with Sustained Systemic Glucocorticoid Treatment who are at Increased Risk for Fracture AND Men and Postmenopausal Women with Osteoporosis who are at High Risk of Fracture
Phase 4
Not yet recruiting
- Conditions
- Osteoporosis without current pathological fracture,
- Registration Number
- CTRI/2023/08/056205
- Lead Sponsor
- Sun Pharmaceutical Industries Limited (SPIL)
- Brief Summary
This is a prospective,phase IV, single arm, multicenter, open-label study. The study will beconducted at approximately 10-15 number of centers in India, having qualifiedInvestigators. The study will be initiated only after the receipt of regulatoryand ethics committee (EC) approval. After obtaining the informed consent,patients will be screened by undergoing various assessments as mentioned inSchedule of Assessment. After confirming the eligibility, patients will be enrolledby allotting the enrollment number. The enrolled patients will be given studydrug Teriparatide Injection [Solution for injection in a pre-filled pen 600mcg/2.4 ml (Synthetic Origin)] 20 mcg once daily subcutaneously. Treatmentduration will be 24 weeks (approximately 6 months). During the study,assessments will be performed as mentioned in Schedule of Assessment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
- Common Inclusion Criteria: 1.Patients who are willing to provide written informed consent and agree to follow the study specific requirement.
- 2.Patients with a diagnosis of osteoporosis who are at high risk for fracture.
- 3.Patients should have at least 2 vertebrae in the L1 to L4 region and at least one hip joint should be evaluable by DXA at the time of screening.
- 4.Male patients must have had a successful vasectomy or they and their female partners must meet the below inclusion criteria no.
- No sperm donation is allowed during the study period.
- Inclusion criteria for Men and Post-menopausal women with Osteoporosis who are at Increased Risk of Fracture: 5.Ambulatory men or post-menopausal women patients of age between > 45 to ≤ 85 years.
- Inclusion criteria for Men and Women with Osteoporosis associated with Sustained Glucocorticoid Use: 6.Ambulatory men or women patients of age ≥ 18 years.
- 7.Patients must be taking a systemic steroid for at least 3 months prior to screening.
- 8.Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication.
Exclusion Criteria
- 1.Patients with history of secondary osteoporosis.
- 2.Patients having history of metabolic bone diseases other than osteoporosis.
- 3.Patients having hypo/hyperthyroidism.
- 4.Patients with primary hyperparathyroidism.
- 5.Patients with severe vitamin D deficiency at screening.
- Vitamin D repletion will be permitted and participants may be rescreened once.
- 7.Patients with history of nephrolithiasis, urolithiasis, or hypercalciuria within 2 years prior to screening.
- 8.Patients who require hospitalization or surgical treatment for osteoporosis as judged by the investigator at time of screening or enrolment.
- 10.Patients with history of hip replacement surgery.
- 11.Patients with significantly impaired hepatic function; multiple transaminase elevation of any magnitude which, in the opinion of the investigator, indicative of significant hepatic impairment as per the investigator’s discretion.
- 12.Patients with unexplained elevations of serum alkaline phosphatase greater than 2 times of ULN, or as per the investigator’s judgement.
- 13.Patients with significantly impaired renal function.
- 14.Patient who have received prior treatment with PTH or parathyroid hormone-related peptide (PTHrP), including abaloparatide.
- 15.Patients who have received previous treatment with bisphosphonates in the last 12 months prior to screening.
- 16.Patients who have received previous treatment with any other drug affecting bone metabolism in the last 3 months prior to screening.
- 17.Patients who are receiving treatment with anticonvulsants that affect Vitamin D metabolism at the time of screening or receiving chronic heparin therapy within the 14 days prior to the screening.
- 18.Patients receiving or intended to receive other unacceptable concomitant medicines.
- 19.Patients with history of any cancer within last 5 years prior to screening.
- 20.Patients with history of osteosarcoma at any time prior to screening.
- 21.Patients who have undergone prior external beam or implant radiation therapy to the skeleton.
- 22.Patients with clinically significant cardiovascular, hepatic, renal, metabolic, hematological, immunological, pulmonary, or gastrointestinal disorders as judged by the investigator.
- 23.Patients with concurrent medical conditions that, in the judgment of the Investigator, might interfere with the conduct of the trial, confounded the interpretation of the trial results, or endangered the patient’s well-being.
- 24.Patients with previous history of gastric bypass surgery, or any medical condition that would be expected to affect drug absorption within last 1 year prior to randomization.
- 25.Patient with history of HIV, Hepatitis B and Hepatitis C.
- 27.Prior participation in any clinical trials, involving experimental or investigational drugs, within 6 months before screening or intended to participate during the study period.
- Patients who have previously participated in any clinical trial involving any experimental PTH or PTHrP preparations are also not eligible for the study.
- 28.Patients with history of hypersensitivity or allergic reaction to study medication or its component(s).
- 29.Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Proportion of patients with treatment-emergent adverse events (TEAEs) Baseline, Week 4, 12 and 24
- Secondary Outcome Measures
Name Time Method Efficacy: Percent change from baseline in total hip BMD at Month 6 Month 6 Efficacy: Percent change from baseline in lumbar spine BMD at Month 3 & 6 Month 3 & 6 Exploratory: Change from baseline in FRAX score (Major osteoporotic fracture) at Month 6 Month 6 Exploratory: Change from baseline in FRAX score (Hip fracture) at Month 6 Month 6 Efficacy: Percent change from baseline in femoral neck BMD at Month 6 Month 6
Trial Locations
- Locations (15)
BGS Global Institute of Medical Science
🇮🇳Bangalore, KARNATAKA, India
Dr. D Y Patil Hospital and Research Center
🇮🇳Thane, MAHARASHTRA, India
Gandhi Hospital
🇮🇳Hyderabad, TELANGANA, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Ishwar Institute of Healthcare
🇮🇳Aurangabad, MAHARASHTRA, India
Medipoint Hospital Pvt. Ltd
🇮🇳Pune, MAHARASHTRA, India
Nil Ratan Sircar Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
NRR Hospital
🇮🇳Bangalore, KARNATAKA, India
Shivam Hospital
🇮🇳Ahmadabad, GUJARAT, India
Sir JJ group of Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Scroll for more (5 remaining)BGS Global Institute of Medical Science🇮🇳Bangalore, KARNATAKA, IndiaDr Raju KPPrincipal investigator9480289496drrajukp.bgsgims@gmail.com