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

JRCT ID: jRCTs071180087

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary osteoporosis
• Date of first enrollment: 25/02/2016
• Target sample size: 130
• Study type: Interventional

Intervention(s)

Administration of the following medicine for 24 months to 130 primary osteoporosis patients with fragility fractures who allocated to the following 3 groups by stratified block randomization.
Group A (40 patients) : daily teriparatide and alfacalcidol.
Group B (50 patients) : weekly teriparatide and alfacalcidol.
Group C (40 patients) : oral bisphosphonate and alfacalcidol.

Outcome(s)

• Primary Outcome: Evaluation of cortical thickness changes after 18 months in the group of daily teriparatide, weekly teriparatide and oral bisphosphonate.

Secondary Outcome

1.The change of bone microarchitecture, estimated bone strength, geometry, bone mineral density and bone metabolism after 6, 18 and 24 months in the group of daily teriparatide, weekly teriparatide and oral bisphosphonate.
2.Comparison of bone microarchitecture, estimated bone strength, geometry, bone mineral density and bone metabolism after 6, 18 and 24 months between the group of daily teriparatide, weekly teriparatide and oral bisphosphonate.

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 89age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Osaki Makoto
• Secondary Sponsor: Chiba Ko
• Source(s) of Monetary Support: Asahi Kasei Pharma Corporation,Eli Lily Japan K.K.
• Secondary ID(s): UMIN000020584