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Alendronate treatment in patients with osteoarthritis of the hip associated with osteoporosis

Alendronate treatment in patients with osteoarthritis of the hip associated with osteoporosis - Alendronate treatment in patients with hip osteoarthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001150
Enrollment
210
Registered
2008-09-01
Start date
2008-07-01
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

Group A: Aspara-CA 1200mg/day administrated every day, for 2 years Group B: Aspara-CA 1200mg/day administrated every day and alendronate 35mg administrated once a week , for 2 years

Sponsors

Osaka Osteo-Arthritis Forum (OAF)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Occurence of pain within 1 month at inclusion of the study 2) Diagnosis with osteoarthritis of the hip at the grade 2 or more according to Kellgren & Lawrence classification 3) Diagnosis with osteoporosis on Lumbar X rays

Exclusion criteria

Exclusion criteria: 1) Patient who has willing to receive surgery of the hip, or who is scheduled to receive surgery of the hip, at the entry of the study 2) Patient who has willing to bear a child or who is a nursing mother 3) Patient who has serious renal disorder 4) Patient who has experiences of receiving bisphosphonate treatment within 6 months at inclusion of the study 5) Patient who has experiences of receiving drugs having influence on bone remodeling rwithin 8 weeks at inclusion of the study (Vitamin D, Calcitonin, Ipriflavone, Vitamin K, Steroid) 6) Patients with primary or secondary hyperparathyroidism, or with rheumatic arthritis 7) Patients with upper gastrointestinal disorders 8) Patients who is diagnosed as contraindication of alendronate treatements

Design outcomes

Primary

MeasureTime frame
1) Plain anteroposterior radiographs of the hip (minimal joint space, position of the center of the femoral head, osteophyte, sclerotic chnage, porotic change) 2) WOMAC hip score, VAS score of the hip and knee Evaluation will be performed at the entry of the study, 3,6,12,18,24 months after start of the study

Secondary

MeasureTime frame
1) Biochemical markers (Urinary NTX-I and CTX-II) 2) DEXA (Lumbar and hip) 3) MRI of the hip 4) Status of administration in alenronate and anti-inflamatory drugs

Countries

Japan

Contacts

Public ContactTakashi Nishii

Osaka University Medical School Department of Orthopaedic Surgery

nishii@ort.med.osaka-u.ac.jp06-6879-3552

Outcome results

None listed

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