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The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty

The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty - Prevention of stress shielding with risedoronate and denosumab

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019874
Enrollment
100
Registered
2015-11-20
Start date
2015-11-24
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Osteoarthritis of the hip

Interventions

subcutaneous injection denosumab, 60mg every 6 months use for 2 years oral risedronate, 17.5mg once weekly, use for 2 years

Sponsors

Shonan Kamakura Joint Reconstruction Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Osteoarthritis of the hip 2) Young Adult Mean< 80% / Proximal femur or Lumbar vertebra

Exclusion criteria

Exclusion criteria: 1) oral Bisphosphonate therapy for more than 3 years 2) oral Bisphosphonate therapy within 6 months prior to the study enrollment 3) oral Bisphosphonate therapy for more than 2 weeks between 6 months and 3 years prior to the study enrollment 4) intravenous Bisphosphonate therapy within 5 years prior to the study enrollment 5) Parathyroid hormone therapy within 6 weeks prior to the study enrollment 6) A history of Osteotomy 7) sever renal dysfunction (GFR< 30) 8) sever liver dysfunction 9) malignant tumor 10) hypocalcemia, hypokalemia 11) A history ofesophagostenosis, esophageal achalasia 12) A history of hyperparathyroidism 13) glucocorticoids therapy 14) pregnant woman 15) The patients should be excluded, who have poor medical compliance, drug-induced allergy, etc.

Design outcomes

Primary

MeasureTime frame
The percentage change in periprosthetic bone mineral density

Secondary

MeasureTime frame
The change in bone mineral density of the vertebra, The percentage change in bone metabolic markers of resorption and formation, Harris Hip Score, Periprosthetic X-ray change

Countries

Japan

Contacts

Public ContactNariaki Nakura

Shonan Kamakura Joint Reconstruction Center Department of Orthopedic

izumi.kokubun@tokushukai.jp0466-47-2377

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026