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

UMIN ID: UMIN000001150

Registered date:01/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Osteoarthritis of the hip
• Date of first enrollment: 2008/07/01
• Target sample size: 210
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Osaka Osteo-Arthritis Forum (OAF)
• Source(s) of Monetary Support: Japan Association of Preventive Medicine for Adult Disease