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

JRCT ID: jRCTs071180086

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary Osteoporosis
• Date of first enrollment: 07/02/2017
• Target sample size: 66
• Study type: Interventional
• Intervention(s): Administration of Ibandronate 1 mg / month, Calcium preparations (combination drug) (New Calcium D 3) for 12 months to 66 patients with primary osteoporosis who had been treated with teriparatide for 12 months or more

Outcome(s)

• Primary Outcome: Change rate of lumbar spine bone mineral density from before administration to 12 months

Secondary Outcome

1) Change rate of lumbar spine bone mineral density from before administration to 6 months.

2) Change rate of femur / radial bone mineral density (aBMD), calcaneous SOS, occurrence rate of vertebral body fracture, bone metabolism marker, rate of change of VAS, cortical bone structure, Cancellous bone structure, bone morphology, change rate of predicted bone strength, lumbar / femoral bone density (vBMD), rate of change of femoral bone morphology, blood test.

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: Not applicable
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Osaki Makoto
• Secondary Sponsor: Chiba Ko
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO., LTD.