Randomized controlled trial of daily teriparatide, weekly teriparatide, or bIsphosphonate in patients with osteoporosis.

Phase 4

• Conditions: Primary osteoporosis

• Registration Number: JPRN-jRCTs071180087
• Lead Sponsor: Osaki Makoto

Brief Summary

We investigated the differences in the effects of daily teriparatide (20 micro g), weekly high-dose teriparatide (56.5 micro g), and bisphosphonate on postmenopausal osteoporosis patients with fragile fractures. D-PTH, W-PTH, and BPs were all shown to improve bone structure, although they exhibited different mechanisms and degrees of effects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Study Completion: 2019-08-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

1.Age: Patients over 60 years old and less than 89 years old.
2.Gender: female.
3.Inpatient or Outpatient: unmentioned.
4.Primary osteoporosis patients with one or more previous fragility fractures (e.g., proximal femoral fracture, vertebral fracture, distal radius fracture, proximal humerus fracture, rib fracture, pelvic fracture, lower leg fracture).
5.Medical history using Vitamin D preparation: unmentioned.
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 serious cardiac disorder, serious liver dysfunction, serious kidney dysfunction, diabetes mellitus, endocrine and metabolic diseases which may affect to the bone metabolism, and secondary osteoporosis (e.g., glucocorticoid-induced osteoporosis, rheumatoid arthritis, immobilization osteoporosis).
2.Patients treated with medication which affect to the bone metabolism as follows,
i)Glucocorticosteroids (within 6 months before enrollment, or >5mg for over 3 months) except inhaler or nasal drip.
ii)Anti-cancer drugs.
iii)Anti-osteoporosis drugs (teriparatide, anti-RANKL antibody, bisphosphonates within 6 months before enrollment, SERMs within 3 months before enrollment, or estrogen preparations).
3.Patients who have contraindication of teriparatide or bisphosphonate.
4.Patients who have severe allergy.
5.Patients enrolled in other clinical studies in the past 3 months.
6.Patients judged to be inadequate for this study by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified