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

NCT00446589 | Terminated Phase 4

• 1 other identifier: 47b/31-1-2005
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.

  one year

Secondary Outcomes (1)

• Effects of ibandronate and teriparatide on other bone disease markers

  one year

Study Arms (2)

F

EXPERIMENTAL

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

Drug: teriparatide

I

EXPERIMENTAL

Hemodialysis pts suffering from osteoporosis who received iv ibandronate

Drug: ibandronate

Interventions

ibandronate DRUG

iv 1mg ibandronate monthly for one year

I

teriparatide DRUG

sc injection using a pen like device during every hemodialysis session (thrice a week)

F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suspected carcinoma
• Unstable clinical setting

Sponsors & Collaborators

• Papageorgiou General Hospital: lead

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, 56403, Greece

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic Acid; Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Efstathios Mitsopoulos, MD

  Papageorgiou General Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: July 1, 2006
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

GR (1)