Denosumab Versus Bisphosphonates (Alendronate) in GIOP | NCT03005678

Studies
Denosumab Versus Bisphosphonates (Alendronate) in GIOP

NCT03005678

Sponsor

Tuen Mun Hospital

Status

Completed

Last Update Posted

Feb 12, 2020Actual

Enrollment

140Actual

Phase

Phase 4

Conditions

Osteoporosis

Interventions

Denosumab
Alendronate

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Feb 1, 2020Actual

First Submitted Date

Dec 24, 2016

First Submission Date that Met QC Criteria

Dec 28, 2016

First Posted Date

Dec 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2020

Last Update Posted Date

Feb 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Treatment arms:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Denosumab	Active Comparator	denosumab subcutaneous 60mg every 6 months	Drug: Denosumab
Alendronate	Placebo Comparator	alendronate 70mg orally every week	Drug: Alendronate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Denosumab	Drug	active treatment group	Denosumab	prolia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone mineral density at lumbar spine	BMD lumbar spine	month 12

Secondary Outcomes

Measure	Description	Time Frame
bone mineral density at the hip	BMD hip	month 12
bone turnover markers	P1NP and osteocalcin	month 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (women or men) >18 years of age
Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
Informed consent from patients.
Willing to comply with all study procedures

Exclusion Criteria:

Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
Premenopausal women who plan for pregnancy within 18 months of study entry.
Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
Patients with unexplained hypocalcemia.
Patients with serum creatinine level of >=200umol/L.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CC Mok	Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Tuen Mun Hospital		Hong Kong		000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069448	Denosumab
D019386	Alendronate

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided