NCT04036929

Brief Summary

Post-menopausal women aged 40-65 with symptomatic hand osteoarthritis are invited to take part in this feasibility study. The study's aim is to investigate whether it is acceptable to women with painful hand OA to take an estrogen-containing therapy, and what is the best way of collecting some of the information in order to facilitate planning a full size trial. The investigator's long-term aim is to find out whether giving estrogen-containing therapy to women after the menopause improves hand OA symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

May 9, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

June 21, 2019

Last Update Submit

April 13, 2022

Conditions

Hand Osteoarthritis

Keywords

OsteoarthritisHandHormonePainEstrogen

Outcome Measures

Primary Outcomes (4)

  • Feasibility: Rates of eligible participant identification, rates of recruitment/randomisation from different sources, retention rates

    From the date of recruitment opening until the date of recruitment closing, 1 year

  • Feasibility: Frequency of adverse events related to the active study medication

    Through study completion, 7 months

  • Feasibility: Bang's Blinding Index (likelihood of unblinding)

    Self-complete questionnaire which assesses likelihood that participant or Investigator have become unblinded

    Week 24

  • Feasibility: Monitoring study medication compliance (via diaries)

    Participants will be asked to record any missed doses of study medication on a paper diary which will be provided at each visit. We will ask participants to bring the diary to each study visit and any missed doses will be recorded in the Case Report Form.

    From randomisation to end of treatment at Week 24

Secondary Outcomes (12)

  • Pain and function: Average hand pain over last 14 days (NRS 0-10)

    Collected at: Baseline, Week 4, Week 12, Week 24

  • Pain and function: Remote pain-rating prior to a visit (NRS 0-10)

    Collected at: Baseline, Week 4, Week 12, Week 24

  • Pain and function: Prevalence of joint pain elsewhere (pain manikin)

    Collected at: Baseline, Week 12, Week 24

  • Pain and function: Functional Index for Hand OA (FIHOA)

    Collected at: Baseline, Week 12, Week 24

  • Pain and function: EQ-5D-5L

    Collected at: Baseline, Week 12, Week 24

  • +7 more secondary outcomes

Study Arms (2)

Estrogen-bazedoxifene

EXPERIMENTAL

Tablet, once daily for 6 months.

Drug: Estrogen-bazedoxifene

Placebo

PLACEBO COMPARATOR

Closely matched tablet, once daily for 6 months.

Drug: Placebo oral tablet

Interventions

Estrogen-bazedoxifeneDRUG

Conjugated estrogens 0.45 mg-bazedoxifene acetate 20 mg.

Also known as: Duavive
Estrogen-bazedoxifene
Placebo oral tabletDRUG

Placebo oral tablet

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed written consent
  • Female, aged 40-65 years old
  • In those with an intact uterus: At least 12 months of spontaneous amenorrhea (without any menstrual bleeding in last 12 months) and last menstrual period not more than 10 years ago
  • In those who have undergone hysterectomy or are/were using an intrauterine contraceptive device with progesterone local therapy (such as Mirena): Follicle stimulating hormone (FSH) ≥30 milli-International Units per millilitre (mIU/ml) on screening blood test AND a history of menopausal symptoms in the last 1 to 10 years, in keeping with appropriate timing of menopausal status
  • Hand pain, aching or stiffness on most days in the last 3 months
  • At least 2, painful hand joints of any type (interphalangeal joints (IPJ) or base of thumbs)
  • Fulfils American College of Rheumatology clinical diagnostic criteria for hand OA (3 or more of following):
  • Hard tissue enlargement of 2 or more of the following joints: 2nd or 3rd distal interphalangeal joints (DIPJ), 2nd or 3rd proximal interphalangeal joints (PIPJ), first carpometacarpal joints (CMCJ)
  • Hard tissue enlargement of 2 or more of the DIPJs
  • Less than 3 swollen metacarpophalangeal joints (MCPJ)
  • Deformity of at least one of the joints listed in first point
  • OR, for those with base of thumb osteoarthritis only not fulfilling these criteria, has clinical symptoms and examination findings consistent with base of thumb osteoarthritis.
  • Hand pain has not responded adequately to National Institute for Health and Care Excellence core guidance for management of OA, including the use of paracetamol or non-steroidal anti-inflammatory drug (NSAID) gel, except where there is contraindication or intolerance
  • Average hand pain is reported as typically more than 4 out of 10 in severity, or average hand pain in the last 7 days of 4/10 or more on a visual analogue scale
  • In the Investigator's opinion, is able and willing to comply with all study requirements

You may not qualify if:

  • Other cause of hand pain, including inflammatory arthritis, connective tissue disorder, chronic pain or alternative clinical diagnosis such as tenosynovitis or carpal tunnel syndrome
  • Pregnancy or breast feeding, or risk of this during study
  • Use of one or more prohibited treatments within specified timeframe, or not willing to avoid treatment for the duration of the study:
  • Anti-estrogen medication within the last 6 months
  • Oral, intramuscular or intraarticular steroid within the last 3 months
  • Intraarticular hyaluronan to a hand joint within the last 6 months
  • Initiation of new oral analgesia within the last 4 weeks
  • Initiation of glucosamine, chondroitin, hand exercises or other relevant non- pharmacological therapy within the last 6 weeks
  • Hand surgery within the last 6 months, or planned within the next 6 months
  • Medications likely to increase hepatic metabolism of study medication, including:
  • St. John's Wort
  • Anti-convulsants (phenobarbital, phenytoin, carbamazepine, lamotrigine)
  • Some anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir)
  • Presence of one or more medical contraindications to the use of systemic hormonal replacement therapy:
  • In those aged 40-45 years, FSH \<30 mIU/ml on screening blood test, i.e. non- confirmatory of menopausal status
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

White Horse Medical Practice, Faringdon Medical Centre

Faringdon, Oxfordshire, SN7 7YU, United Kingdom

Location

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7HE, United Kingdom

Location

Related Publications (1)

  • Marian IR, Goff M, Williams JAE, Gulati M, Chester-Jones M, Francis A, Watson M, Vincent TL, Woollacott S, Mackworth-Young C, Glover V, Furniss D, Gardiner M, Lamb SE, Vincent K, Barber VS, Black J, Dutton SJ, Watt FE. Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial. Pilot Feasibility Stud. 2021 Jun 24;7(1):133. doi: 10.1186/s40814-021-00869-1.

    PMID: 34167594BACKGROUND

Related Links

MeSH Terms

Conditions

OsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2019

First Posted

July 30, 2019

Study Start

May 9, 2019

Primary Completion

August 19, 2021

Study Completion

December 10, 2021

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Access to the de-identified dataset for purposes of research other than this study, would be at the discretion of the Chief Investigator, Dr Fiona Watt and OCTRU. All participants have consented to the information collected about them from the study may be used in a de-identified form to support other research on hand osteoarthritis in the future and may in certain circumstances be passed on to other collaborators of the research team in organisations other than the University of Oxford, which may include those outside the EU and commercial organisations. Requests for the de-identified dataset generated during the current study should be made to the Chief Investigator, Dr Fiona Watt (fiona.watt@kennedy.ox.ac.uk) or OCTRU (octrutrialshub@ndorms.ox.ac.uk). Dr Fiona Watt and OCTRU will consider requests once the main results from the study have been published up until 10 Dec 2036 . All requests must relate to bone fide research into hand osteoarthritis research.

Locations

GB(3)