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CompletedNCT03005678Updated Feb 12, 2020

Denosumab Versus Bisphosphonates (Alendronate) in GIOP

A Phase 4 interventional study of Denosumab and Alendronate in Osteoporosis, sponsored by Tuen Mun Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by Tuen Mun Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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)
02

Conditions studied

  • Osteoporosis

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Keywords

  • glucocorticoids, steroids, osteoporosis
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 140 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Tuen Mun Hospital is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    Denosumab

    denosumab subcutaneous 60mg every 6 months

    Drug: Denosumab

  • Placebo comparator
    Alendronate

    alendronate 70mg orally every week

    Drug: Alendronate

Interventions

  • DrugDenosumab

    active treatment group

    Also known as: prolia

  • DrugAlendronate

    comparator

    Also known as: fosamax

06

What researchers measure

Primary outcomes

  1. bone mineral density at lumbar spine

    BMD lumbar spine

    Time frame: month 12

Secondary outcomes

  1. bone mineral density at the hip

    BMD hip

    Time frame: month 12

  2. bone turnover markers

    P1NP and osteocalcin

    Time frame: month 12

  3. adverse events

    adverse events

    Time frame: month 12

07

Study locations

1 site
  • Department of Medicine, Tuen Mun Hospital
    Hong Kong, 000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03005678
Lead sponsor
Tuen Mun Hospital
Responsible party
Chi Chiu Mok (Principal investigator, Tuen Mun Hospital) — Principal investigator
First posted
Dec 29, 2016
Start date
Apr 1, 2017
Primary completion
Nov 1, 2019
Completion
Feb 1, 2020
Last update
Feb 12, 2020

Study contacts

CC Mok
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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