FindTrial
Sign In

The Effects Of Denosumab On Bone health in renal Allograft Transplant Patients.

A Prospective Randomized Controlled Study To Analyze The Effects Of Denosumab On Bone Mineral Density And Bone Metabolism Indices In Renal Allograft Transplant Patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038018
Enrollment
50
Registered
2021-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Administration of Denosumab in Renal transplant patients: Methods: Patients meeting inclusion criteria will be will be randomized into two groups: Group A and Group B, using random numb

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • All patients 18 years and above undergoing renal allograft transplant in the Department of Renal Transplant Surgery, PGIMER Chandigarh.

Exclusion criteria

Exclusion criteria: • Allograft dysfunction: Serum creatinine value above 2.5mg/dl at three weeks post transplantation. • Patient with severe hyperparathyroidism or hypoparathyroidism (iPTH >800 or • Patients with severe hypocalcaemia or hypercalcemia (total calcium 11mg/dl) prior to transplant. • If subject failed to lay supine position during DEXA scan.

Design outcomes

Primary

MeasureTime frame
oTo assess the changes in bone mineral density of lumbar spine and hip in a time dependant manner serially at 6 months and 12 months after renal transplantation in patients receiving and not receiving denosumab. oTo compare the changes in bone turnover post renal transplantation serially at and 12 months in patients who receive and do not receive denosumab. Timepoint: oTo assess the changes in bone mineral density of lumbar spine and hip in a time dependant manner serially at 6 months and 12 months after renal transplantation in patients receiving and not receiving denosumab. oTo compare the changes in bone turnover post renal transplantation serially at and 12 months in patients who receive and do not receive denosumab.—

Secondary

MeasureTime frame
o To assess and compare changes in bone histomorphometry on bone biopsy at zero hour and at 12 months post-transplant in patients who receive and do not receive denosumab. o To compare the risk of renal allograft rejection between these two groups. Timepoint: 1 year 3 months—

Countries

India

Contacts

Public ContactDr Amit Sharma

PGIMER Chandigarh

ashish_chd@hotmail.com9914202301

Outcome results

None listed

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