OsteoporosisPhase 3NCT00004650
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
A Phase 3 study testing conjugated estrogens and Medroxyprogesterone in people with Osteoporosis, run by National Institute of Dental and Craniofacial Research (NIDCR).
Trial summary
OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women. II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients. III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- conjugated estrogens and Medroxyprogesterone
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 1993to not given
- Phase
- Phase 3
- 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 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
- Women postmenopausal for at least 2 years
- At least 10 teeth for which radiographic measurements can be obtained, i.e.: Not severely tilted Not so closely spaced that interproximal bone is thin Not in positions of restricted access
About this study
OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.
II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.
III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years.
Participants in the placebo group may be removed from study if bone loss exceeds 5% per year.
A study duration of 3 years is anticipated.
- Conditions
- Osteoporosis
- Being tested
- conjugated estrogens, Medroxyprogesterone
- Keywords
- disease-related problem/condition, osteoporosis, rare disease
- Medical subject headings
- Osteoporosis, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjugated estrogensDrug
MedroxyprogesteroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startAug 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Washington University School of Medicine
- Investigators
- Charles F. Hildebolt, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004650
- Sponsor's protocol ID
- 199/11726
- Other IDs
- WUSM-900449
- Status last verified
- Jun 1999
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Hildebolt CF, Pilgram TK, Dotson M, Yokoyama-Crothers N, Muckerman J, Hauser J, Cohen S, Kardaris E, Vannier MW, Hanes P, Shrout MK, Civitelli R. Attachment loss with postmenopausal age and smoking. J Periodontal Res. 1997 Oct;32(7):619-25. doi: 10.1111/j.1600-0765.1997.tb00940.x.
PubMed 9401935Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. doi: 10.1038/sj.dmfr.4600226.
PubMed 9446984Hildebolt CF, Brunsden B, Yokoyama-Crothers N, Pilgram TK, Townsend KE, Vannier MW, Shrout MK. Comparison of reliability of manual and computer-intensive methods for radiodensity measures of alveolar bone loss. Dentomaxillofac Radiol. 1998 Jul;27(4):245-50. doi: 10.1038/sj/dmfr/4600352.
PubMed 9780904
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
- ClinicalTrials.gov ID
- NCT00004650
- Acronym / sponsor ID
- 199/11726
- Conditions
- Osteoporosis
- Keywords
- disease-related problem/condition, osteoporosis, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Collaborators
- Washington University School of Medicine
- Study start
- Aug 1993
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.
II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.
III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years.
Participants in the placebo group may be removed from study if bone loss exceeds 5% per year.
A study duration of 3 years is anticipated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conjugated estrogens | Drug | – |
| Medroxyprogesterone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 9401935Hildebolt CF, Pilgram TK, Dotson M, Yokoyama-Crothers N, Muckerman J, Hauser J, Cohen S, Kardaris E, Vannier MW, Hanes P, Shrout MK, Civitelli R. Attachment loss with postmenopausal age and smoking. J Periodontal Res. 1997 Oct;32(7):619-25. doi: 10.1111/j.1600-0765.1997.tb00940.x.
- Background: PubMed 9446984Hildebolt CF. Osteoporosis and oral bone loss. Dentomaxillofac Radiol. 1997 Jan;26(1):3-15. doi: 10.1038/sj.dmfr.4600226.
- Background: PubMed 9780904Hildebolt CF, Brunsden B, Yokoyama-Crothers N, Pilgram TK, Townsend KE, Vannier MW, Shrout MK. Comparison of reliability of manual and computer-intensive methods for radiodensity measures of alveolar bone loss. Dentomaxillofac Radiol. 1998 Jul;27(4):245-50. doi: 10.1038/sj/dmfr/4600352.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles F. Hildebolt study chair
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conjugated estrogens and Medroxyprogesterone in people with Osteoporosis, run by National Institute of Dental and Craniofacial Research (NIDCR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004650, which also lists 3 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 24 Jun 2005.