The Effect of Low Dose Hormone Replacement Therapy or Raloxifene on Bone and Lipid Metabolism in Hemodialysis Patients

UMIN ID: C000000390

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Postmenopausal osteopenia in hemodialysis patients
• Date of first enrollment: 2004/08/01
• Target sample size: 39
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Transdermal low dose estrogen replacement therapy with cyclic administration of medroxyprogesterone acetate at 3-month interval
Oral administration of raloxifene every two days
No drug intervention

Outcome(s)

• Primary Outcome: Changes in serum calcium, phosphorus, parathyroid hormone, bone markers and lipid metabolism
• Secondary Outcome: Change in bone mineral density at the radius on the side without atrio-venous fistula

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1. Patients with arteriosclerosis obliterans 2. Patients at high risk of venous thrombosis. i.e. bedridden patients 3. Patients with history of uterine cancer and/or breast cancer. 4. Patients receiving specific treatments other than active vitamin D that affect bone and mineral metabolism. i.e. calcitonin, bisphosphonate, and recombinant human PTH.

Related Information

• Primary Sponsor: Department of Nephrology, Osaka University School of Medicine
• Secondary Sponsor: Dai-Ni Rokushima Clinic Imai Naika Clinic Obi Clinic
• Source(s) of Monetary Support: None