The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

Papageorgiou General Hospital

Status and phase: Terminated; Phase 4

Conditions: Osteoporosis

Treatments: Drug: teriparatide; Drug: ibandronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00446589

47b/31-1-2005

Details and patient eligibility

About

Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).

Follow-up period: one year. A second bone biopsy at the end of the study.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bone mineral density (T-score<-2.5)
• Adynamic bone disease for the teriparatide group
• Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
• Calcium greater than 8.1 mg/dl

Exclusion criteria

• Suspected carcinoma
• Unstable clinical setting

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

F

Experimental group

Description:

HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide

Treatment:

Drug: teriparatide

I

Experimental group

Description:

Hemodialysis pts suffering from osteoporosis who received iv ibandronate

Treatment:

Drug: ibandronate