NCT04321837

Brief Summary

This study will investigate the effect of coral calcium complex supplementation on BMD of osteoporotic individuals either when used alone or in combination with ibandronate. Ibandronate alone will also be tested in comparison to coral calcium supplementation alone or in combination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

3.1 years

First QC Date

March 23, 2020

Last Update Submit

May 7, 2024

Conditions

Osteoporosis, Postmenopausal

Keywords

CalciumCoral calciumIbandronate

Outcome Measures

Primary Outcomes (4)

  • Mean change in bone mineral density (BMD) (lumbar spine)

    Participant bone mineral density of lumbar spine.

    48 weeks

  • Mean change in BMD (femoral neck)

    Participant bone mineral density of femoral neck.

    48 weeks

  • Mean change in BMD (total hip)

    Participant bone mineral density of total hip.

    48 weeks

  • Mean change in BMD (forearm)

    Participant bone mineral density of forearm.

    48 weeks

Study Arms (3)

Coral calcium complex and ibandronate

ACTIVE COMPARATOR
Dietary Supplement: Coral Complex 3Drug: Ibandronate

Ibandronate and vitamin D

ACTIVE COMPARATOR
Drug: IbandronateDietary Supplement: Vitamin D3

Coral calcium complex

ACTIVE COMPARATOR
Dietary Supplement: Coral Complex 3

Interventions

Coral Complex 3DIETARY_SUPPLEMENT

Coral-derived calcium supplement fortified with vitamin D3

Coral calcium complexCoral calcium complex and ibandronate
IbandronateDRUG

Bisphosphonate

Coral calcium complex and ibandronateIbandronate and vitamin D
Vitamin D3DIETARY_SUPPLEMENT

Oral vitamin D3

Ibandronate and vitamin D

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women, 50-75 years of age (inclusive). Menopause is defined as no menstrual period for 1 year.
  • BMD T-score of lumbar spine (L1-L4), femoral neck, total hip, or non-dominant forearm \< -2.5 as determined by DXA.

You may not qualify if:

  • T-score of lumbar spine, femoral neck, total hip, or non-dominant forearm \< -3.5.
  • Use of any supplemental calcium preparations in the past 1 year.
  • Use of ibandronate in the past 3 years.
  • Current use of
  • prednisone or other corticosteroid,
  • antiseizure medications,
  • thiazide diuretics, or
  • estrogen preparation except vaginal cream.
  • Electrolyte abnormalities, as defined by abnormal blood levels of sodium (Na), chlorine (Cl), potassium (K), phosphate (Phos), calcium (Ca), or magnesium (Mg) values on initial screen.
  • Chronic disease, including
  • liver disease (as defined by elevated blood levels of aspartate aminotransferase, alanine aminotransferase, and/or alkaline phosphatase or reduced albumin or total protein on initial screen),
  • stage III renal disease or worse (as defined by epidermal growth factor receptor (eGFR) \< 60 cc/min),
  • abnormal thyroid function tests,
  • current parathyroid disease (as defined by hypercalcemia and elevated levels of parathyroid hormone (PTH) - if history of hyperparathyroidism, surgical cure has to be documented more than 5 years ago),
  • diabetes mellitus,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osteoporosis Center of Armenia

Yerevan, Armenia

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic AcidCholecalciferol

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • John P Bilezikian, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dorothy L. and Daniel H. Silberberg Professor of Medicine and Professor of Pharmacology

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

February 5, 2020

Primary Completion

March 13, 2023

Study Completion

March 13, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)