Effects of monthly injected ibandronate on bone mineral density and microstructure.

Phase 4

• Conditions: Primary Osteoporosis

• Registration Number: JPRN-jRCTs071180086
• Lead Sponsor: Osaki Makoto

Brief Summary

In patients with primary osteoporosis treated with teriparatide, switching to intravenous ibandronate decreased bone resorption markers by 43.9%, increased lumbar bone mineral density by 3.5%, and HR-pQCT tibial cortical bone thickness by 2.6% and decreased BR showing cortical instability by 2.5%. The effectiveness of sequential treatment with ibandronate on bone density and cortical bone microstructure was confirmed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Study Completion: 2019-05-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1.Patients who underwent teriparatide treatment for primary osteoporosis for 12 consecutive months or more (confirmed compliance with over 75% during the period)
2.Patients who can receive ibandronate within 8 weeks from the final administration of teriparatide
3.Age: Patients over 55 years old
4.Gender: female
5.Outpatient
6.After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding

Exclusion Criteria

1.Patients with the following underlying diseases:
Serious heart disease, liver disease, renal disorder, diabetes, active malignant tumor
Endocrine, metabolic diseases affecting bone metabolism
Secondary osteoporosis (steroid, rheumatoid arthritis, immobility)
2.Patient with the following medication
Steroid: 5 mg or more Use experience of 3 months or more (excluding inhaled steroids)
Agents affecting bone metabolism (drugs for malignant tumor etc.)
3.Patient falling under any of the contraindication items of drugs used:
Patients with a history of hypersensitivity to components of ibandronate formulation or other bisphosphonate drugs
Patients with hypocalcemia
4.Patients who participated in the clinical trial within 4 months
5.Patients who were confirmed to have three or more existing fractures in the first to fourth lumbar vertebrae by X-ray radiophotography during the observation period
6.In addition, patients whose research managers judged inappropriate as research subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified