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Arthritis, RheumatoidPhase 4NCT02602704

Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients

A Phase 4 study testing Bazedoxifene and Calcium/Vit D in people with Arthritis, Rheumatoid, run by Hanyang University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to study the effectiveness of bazedoxifene in preventing loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs. Read more about this study

Who is it for?
Ages 45 years and older, women only
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Bazedoxifene and Calcium/Vit D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteSouth Korea
Study dates
29 Dec 2015to 1 Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female RA patients ≥ 45 years old with self-reported postmenopausal for ≥12 months or prior hysterectomy with bilateral oophorectomy. Female patients ≥ 55 years old who had prior hysterectomy without oophorectomy or with unilateral oophorectomy.
  • Having been receiving low to moderate dose of glucocorticoids (prednisone ≤7.5 mg/day or equivalent) for ≥3 months prior to entry. (When taking glucocorticoids PRN, prednisone ≥1mg/day in average.)
  • Patients expected to be on glucocorticoid treatment for 3 months after entry.
  • Patients with an osteopenic mean lumbar spine (LS; L1-L4) or femoral neck bone mineral density (BMD; -1 < T-score < -2.5)
  • Patients who provide a written consent of participating in this study.

Who cannot join

  • Patients with condition that may interfere with the evaluation of spinal or hip osteoporosis by DXA such as two or more vertebral (L1-L4) fractures or other vertebral deformity
  • Patients with hypercoagulability risk factors or a history of deep vein thrombosis and pulmonary embolism
  • History of allergic reactions or intolerance to bazedoxifene or other SERM
  • Patients receiving bisphosphonates, parathyroid hormone, SERMs, or anticonvulsants therapies within 6 months prior to entry
  • Patients with known bone disorders such as osteomalacia, renal osteodystrophy and hyperparathyroidism
  • Patients with undiagnosed uterine bleeding
  • Patients with severe renal impairment or creatinine clearance <30ml/min

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hanyang University

    Seoul, 04763

Other trials in South Korea

About this study

  • The purpose of this study is to study the effectiveness of bazedoxifene in preventing loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs.
  • This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene (20 mg/day) or none.
Read the detailed description
  • The purpose of this study is to study the effectiveness of bazedoxifene in preventing loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs.
  • This was a randomized, controlled, open-label study conducted for 56 weeks. Four trial visits occurred over the course of the 56 weeks. At study entry, all patients who took elemental calcium (1200 mg daily) and vitamin D (800 IU daily) were assigned by blocks of two to receive either bazedoxifene (20 mg/day) (bazedoxifene group) or not (control group).
  • Randomization was performed by an independent coordinator. Participants were followed-up at 24 weeks and 48 weeks with special attention to RA flares and occurrence of AEs.
  • Demographic characteristics such as age, sex, and medications related to RA, as well as laboratory result such as complete blood count (CBC), chemistry, and levels of inflammatory markers were collected at enrollment. BMD and trabecular bone score (TBS) were assessed at 0 and 48 weeks, and levels of bone turnover markers were assessed at 0, 24, and 48 weeks. At 56 weeks, the occurrence of AEs was assessed.
Being tested
Bazedoxifene, Calcium/Vit D
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BazedoxifeneDrug

    Also called Viviant

    Bazedoxifene 20mg/day (Viviant) for 48 weeks

  • Calcium/Vit DDrug

    Also called Hardcal Chewable

    Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day) for 48 weeks

Study groups in NCT02602704
Study groupRoleWhat they receive
Bazedoxifene & Calcium/Vit DActive comparator* Enrollment: 57 * Drug: Bazedoxifene 20 mg/day (Viviant) * Drug: Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day)
Receives: Drug: Bazedoxifene; Drug: Calcium/Vit D
Calcium/Vit DActive comparator* Enrollment: 57 * Drug: Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day)
Receives: Drug: Calcium/Vit D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Bone Mineral Density (BMD)

    BMD of the L-spine (L1-4) and femur neck was assessed by dual-energy x-ray absorptiometry (DXA) (Hologic®, Discovery W, Hologic APEX software version 2.3.1; Bedford, MA, USA). BMD in the L-spine was estimated as the mean of individual measurements for L1-L4 excluding any fractured or otherwise deformed vertebrae. The technician who was responsible for measuring BMD was blinded to the details of the study.

    Measured: Baseline and 48 weeks

Secondary outcomes (7)

  1. Change of Trabecular Bone Score (TBS)

    Lumbar spine TBS is obtained using the spine DXA scan archived from the baseline and 48 weeks tests. It is calculated after reanalysis of the DXA scan of the L-spine using TBS iNsight® software (Version 2.0.0.1, Med-Imaps, Bordeaux, France). Vertebrae excluded in the calculation of BMD are also excluded in the TBS calculation.

    Measured: Baseline and 48 weeks

  2. Development of the thoracic and lumbar vertebrae for deformities by visual inspection

    Baseline vertebral fracture is defined as a loss of at least 25% of vertebral height through the thoracic spine X-ray and the lumbar spine X-ray. Incident vertebral fractures at 48 weeks is diagnosed when there were distinct alterations in the morphology of the vertebral bodies that resulted in the loss of at least 25% of vertebral height of previously normal vertebrae.

    The location, the date of occurrence and the severity of fracture (mild, moderate, severe, etc.) are described.

    Measured: Baseline and 48 weeks

  3. Development of any fractures including nonvertebral fractures

    Measured by the questionnaire for fracture. Check item: the location and the date of occurrence of fracture.

    Measured: Baseline, 24 weeks and 48 weeks

  4. Change in serum C-terminal telopeptide (CTX)

    Serum C-telopeptide levels (ng/ml) are assayed by electrochemiluminescence (Roche Diagnostics, GmbH, Mannheim, Germany). Blood samples are collected after at least an 8-hour fast.

    Measured: Baseline, 24 weeks and 48 weeks

  5. Change in urine N-telopeptide (NTX)

    Urine N-telopeptide levels (ng/ml) are measured by chemiluminescence (Ortho Clinical Diagnostics, New York, USA) using commercially available kits. Urine samples are collected after at least an 8-hour fast.

    Measured: Baseline, 24 weeks and 48 weeks

  6. Change in serum bone specific alkaline phosphatase

    Serum bone-specific alkaline phosphatase (ALP) levels (µg/L) are also determined by electrochemiluminescence using commercial kits (Beckman Coulter Inc., Brea, USA). Blood samples are collected after at least an 8-hour fast.

    Measured: Baseline, 24 weeks and 48 weeks

  7. Change in serum osteocalcin

    Serum osteocalcin levels (ng/mL) are also determined by electrochemiluminescence using commercial kits (Beckman Coulter Inc., Brea, USA). Blood samples are collected after at least an 8-hour fast.

    Measured: Baseline, 24 weeks and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study start29 Dec 2015
  3. Primary completion11 Oct 2017
  4. Study completion1 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02602704
Sponsor's protocol ID
HUHRD-SPE-15-05
Other IDs
WI205578
Status last verified
Aug 2020
First submitted
5 Nov 2015
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cho SK, Song YJ, Kim HW, Nam E, Jeon JY, Yoo HJ, Sung YK. Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: a prospective observational study. Rheumatology (Oxford). 2025 Feb 1;64(2):541-547. doi: 10.1093/rheumatology/keae109.

    PubMed 38366621

  • Cho SK, Kim H, Lee J, Nam E, Lee S, Choi YY, Sung YK. Effectiveness of bazedoxifene in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients. Arthritis Res Ther. 2021 Jul 2;23(1):176. doi: 10.1186/s13075-021-02564-1.

    PubMed 34215316

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bazedoxifene and Calcium/Vit D in people with Arthritis, Rheumatoid, run by Hanyang University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Bone Mineral Density (BMD) (time frame: Baseline and 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02602704, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.

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