Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Osteoporosis Clinical Trial

Official title:

Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005678
• Other study ID #: CREC/16
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

Description:

Study design: an open-label randomized controlled trial Duration of study: 12 months

Treatment arms:

1. Denosumab: a total of 2 doses in a period of 12 months

2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults (women or men) >18 years of age

2. Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of =2.5mg/day for =12 months).

3. Informed consent from patients.

4. Willing to comply with all study procedures

Exclusion Criteria:

1. Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.

2. Premenopausal women who plan for pregnancy within 18 months of study entry.

3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.

4. Patients with unexplained hypocalcemia.

5. Patients with serum creatinine level of >=200umol/L.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Denosumab
active treatment group
• Alendronate
comparator

Locations

Country	Name	City	State
China	Department of Medicine, Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density at lumbar spine	BMD lumbar spine	month 12
Secondary	bone mineral density at the hip	BMD hip	month 12
Secondary	bone turnover markers	P1NP and osteocalcin	month 12
Secondary	adverse events	adverse events	month 12