Study in postmenopausal women with osteoporosis

Prospective, multicenter,randomized,double blind, two arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-045/Prolia in postmenopausal women with osteoporosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013924

Enrollment

159

Registered

2018-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Post-menopausal women with osteoporosis

Interventions

Intervention1: R-TPR-045: Denosumab 60 mg S.C Injection every 6 months for 12 months Control Intervention1: ProliaÂ®: Denosumab 60 mg S.C. Injection every 6 months for 12 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Postmenopausal ambulatory woman 2. Patients with BMD value consistent with a T-score between -2.5 to -4.0 at either lumbar spine or hip. 3. Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Pagetâ??s disease, Cushingâ??s disease or Hyperprolactinemia 2. Patients with severe, untreated hypocalcaemia or hypercalcemia 3. Patients with Vitamin D deficiency; Vitamin D supplements will be permitted and patient can be retested for Vitamin D. 4. Current hyperparathyroidism or hypoparathyroidism 5. Uncontrolled Hyperthyroidism or hypothyroidism except patients on stable thyroid hormone replacement therapy for last one year 6. Any clinical fracture within last 6 months prior to screening and/or any vertebral fracture on screening spinal X-ray 7. Prior use of denosumab; hypersensitivity to the denosumab or any of the excipients 8. Received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason 9.Height, weight or girth that has a potential to preclude accurate DXA measurements 10.Patient with severe renal impairment (creatine clearance <30 mL/min) or receiving dialysis.

Design outcomes

Primary

Measure	Time frame
Percent change in BMD and T-score at lumbar spine and hipTimepoint: From Baseline to 12 months	—

Secondary

Measure	Time frame
To evaluate other efficacy parameters, pharmacokinetics, pharmacodynamics, safety and tolerability of R-TPR-045 / ProliaÂ® (Denosumab)Timepoint: From Baseline to 12 months	—

Countries

India

Contacts

Public ContactRavikiran Payghan

Reliance Life Sciences Pvt Ltd.

jamila.joseph@ril.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026