OsteoporosisPhase 3NCT00089791

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

A Phase 3 study testing Denosumab in people with Osteoporosis, run by Amgen.

Completed

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

Trial summary

This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis. Read more about this study

Who is it for?: Ages 60 to 90 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: Denosumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7,808 participants
Where: No sites listed yet
Study dates: 1 Aug 2004to 17 Jun 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 to 90 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women who are 60 to 90 years of age may be eligible to participate
Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

Who cannot join

BMD T-Score at the hip or the spine of less than -4.0
Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry

About this study

Official title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.

Conditions: Osteoporosis
Being tested: placebo, Denosumab
Keywords: Postmenopausal Osteoporosis
Medical subject headings: Osteoporosis, Osteoporosis, Postmenopausal

What participants receive

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

placeboDrug
Placebo administered by subcutaneous injection
DenosumabDrug
Also called AMG 162, Prolia®
Denosumab 60 mg administered by subcutaneous injection

Study groups in NCT00089791
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo administered subcutaneously once every 6 months for 3 years. Receives: Drug: placebo
Denosumab 60 mg Q6M	Experimental	Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years. Receives: Drug: Denosumab

What is being measured

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

Number of Participants With New Vertebral Fractures
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).
Measured: 36 months

Secondary outcomes (2)

Number of Participants With Nonvertebral Fractures
Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary.
Measured: 36 months
Number of Participants With a Hip Fracture
Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.
Measured: 36 months

Timeline

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

1 Aug 200417 Jun 2008

First posted16 Aug 2004 (estimated)
Study start1 Aug 2004
Primary completion17 Jun 2008
Study completion17 Jun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (33)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
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
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 7,808 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00089791
Sponsor's protocol ID: 20030216
Status last verified: Nov 2022
First submitted: 13 Aug 2004
Last updated: 8 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Adami S, Libanati C, Boonen S, Cummings SR, Ho PR, Wang A, Siris E, Lane J; FREEDOM Fracture-Healing Writing Group; Adachi JD, Bhandari M, de Gregorio L, Gilchrist N, Lyritis G, Moller G, Palacios S, Pavelka K, Heinrich R, Roux C, Uebelhart D. Denosumab treatment in postmenopausal women with osteoporosis does not interfere with fracture-healing: results from the FREEDOM trial. J Bone Joint Surg Am. 2012 Dec 5;94(23):2113-9. doi: 10.2106/JBJS.K.00774.
PubMed 23097066
Austin M, Yang YC, Vittinghoff E, Adami S, Boonen S, Bauer DC, Bianchi G, Bolognese MA, Christiansen C, Eastell R, Grauer A, Hawkins F, Kendler DL, Oliveri B, McClung MR, Reid IR, Siris ES, Zanchetta J, Zerbini CA, Libanati C, Cummings SR; FREEDOM Trial. Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures. J Bone Miner Res. 2012 Mar;27(3):687-93. doi: 10.1002/jbmr.1472.
PubMed 22095631
Bolognese MA, Teglbjaerg CS, Zanchetta JR, Lippuner K, McClung MR, Brandi ML, Hoiseth A, Lakatos P, Moffett AH, Lorenc RS, Wang A, Libanati C. Denosumab significantly increases DXA BMD at both trabecular and cortical sites: results from the FREEDOM study. J Clin Densitom. 2013 Apr-Jun;16(2):147-53. doi: 10.1016/j.jocd.2012.02.006. Epub 2012 Apr 20.
PubMed 22521543
Boonen S, Adachi JD, Man Z, Cummings SR, Lippuner K, Torring O, Gallagher JC, Farrerons J, Wang A, Franchimont N, San Martin J, Grauer A, McClung M. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab. 2011 Jun;96(6):1727-36. doi: 10.1210/jc.2010-2784. Epub 2011 Mar 16.
PubMed 21411557
Brown JP, Roux C, Torring O, Ho PR, Beck Jensen JE, Gilchrist N, Recknor C, Austin M, Wang A, Grauer A, Wagman RB. Discontinuation of denosumab and associated fracture incidence: analysis from the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial. J Bone Miner Res. 2013 Apr;28(4):746-52. doi: 10.1002/jbmr.1808.
PubMed 23109251
Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11.
PubMed 19671655
Eastell R, Christiansen C, Grauer A, Kutilek S, Libanati C, McClung MR, Reid IR, Resch H, Siris E, Uebelhart D, Wang A, Weryha G, Cummings SR. Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):530-7. doi: 10.1002/jbmr.251.
PubMed 20839290
Freemantle N, Cooper C, Diez-Perez A, Gitlin M, Radcliffe H, Shepherd S, Roux C. Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis. Osteoporos Int. 2013 Jan;24(1):209-17. doi: 10.1007/s00198-012-2068-9. Epub 2012 Jul 26.
PubMed 22832638
Genant HK, Libanati C, Engelke K, Zanchetta JR, Hoiseth A, Yuen CK, Stonkus S, Bolognese MA, Franek E, Fuerst T, Radcliffe HS, McClung MR. Improvements in hip trabecular, subcortical, and cortical density and mass in postmenopausal women with osteoporosis treated with denosumab. Bone. 2013 Oct;56(2):482-8. doi: 10.1016/j.bone.2013.07.011. Epub 2013 Jul 17.
PubMed 23871852
Hadji P, Bock O, Resch H, Kraenzlin M, Wang A, Steinle T, Eisen C. Reduction of fracture risk with denosumab among women with osteoporosis with or without need for treatment according to DVO 2009 guideline : A subgroup analysis of the FREEDOM trial. Osteologie. 2013;22(1):39-45.
Jamal SA, Ljunggren O, Stehman-Breen C, Cummings SR, McClung MR, Goemaere S, Ebeling PR, Franek E, Yang YC, Egbuna OI, Boonen S, Miller PD. Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res. 2011 Aug;26(8):1829-35. doi: 10.1002/jbmr.403.
PubMed 21491487
Keaveny TM, McClung MR, Genant HK, Zanchetta JR, Kendler D, Brown JP, Goemaere S, Recknor C, Brandi ML, Eastell R, Kopperdahl DL, Engelke K, Fuerst T, Radcliffe HS, Libanati C. Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab. J Bone Miner Res. 2014 Jan;29(1):158-65. doi: 10.1002/jbmr.2024.
PubMed 23794225
Mackey DC, Black DM, Bauer DC, McCloskey EV, Eastell R, Mesenbrink P, Thompson JR, Cummings SR. Effects of antiresorptive treatment on nonvertebral fracture outcomes. J Bone Miner Res. 2011 Oct;26(10):2411-8. doi: 10.1002/jbmr.446.
PubMed 21710615
McCloskey EV, Johansson H, Oden A, Austin M, Siris E, Wang A, Lewiecki EM, Lorenc R, Libanati C, Kanis JA. Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. J Bone Miner Res. 2012 Jul;27(7):1480-6. doi: 10.1002/jbmr.1606.
PubMed 22431426
McClung MR, Boonen S, Torring O, Roux C, Rizzoli R, Bone HG, Benhamou CL, Lems WF, Minisola S, Halse J, Hoeck HC, Eastell R, Wang A, Siddhanti S, Cummings SR. Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis. J Bone Miner Res. 2012 Jan;27(1):211-8. doi: 10.1002/jbmr.536.
PubMed 21976367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
ClinicalTrials.gov ID: NCT00089791
Acronym / sponsor ID: 20030216
Conditions: Osteoporosis
Keywords: Postmenopausal Osteoporosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 7,808 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Aug 2004 (actual)
Primary completion: 17 Jun 2008 (actual)
Study completion: 17 Jun 2008 (actual)
First posted: 16 Aug 2004 (estimated)
Results: Posted 10 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboPlacebo administered subcutaneously once every 6 months for 3 years.
Denosumab 60 mg Q6M	Experimental	Drug: DenosumabDenosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.

Who may qualify

Ages: 60 to 90 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Women who are 60 to 90 years of age may be eligible to participate
Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

Key exclusion criteria (2 listed)

BMD T-Score at the hip or the spine of less than -4.0
Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry

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
placeboPlacebo administered by subcutaneous injection	Drug	Placebo
DenosumabAlso: AMG 162, Prolia®Denosumab 60 mg administered by subcutaneous injection	Drug	Denosumab 60 mg Q6M

Primary outcome

Number of Participants With New Vertebral Fractures
Time frame: 36 months
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).

2 secondary outcomes

Number of Participants With Nonvertebral Fractures
Time frame: 36 months
Number of Participants With a Hip Fracture
Time frame: 36 months

Results and safety

Results posted to the registry on 10 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	3,906	3,206
Denosumab 60 mg Q6M	3,902	3,272

Primary outcome: Number of Participants With New Vertebral Fractures

Time frame: 36 months. Number. Unit: Participants

Measure	Placebo n = 3691	Denosumab 60 mg Q6M n = 3702
Value	264	86

Placebo vs Denosumab 60 mg Q6M: Risk Ratio (RR): 0.32 (95% CI 0.26 to 0.41), p <0.0001, Mantel Haenszel

Population analysed: Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	972 of 3,876 (25.1%)	3,107 of 3,876 (80.2%)	Not reported
Denosumab 60 mg Q6M	1,004 of 3,886 (25.8%)	3,073 of 3,886 (79.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23097066Adami S, Libanati C, Boonen S, Cummings SR, Ho PR, Wang A, Siris E, Lane J; FREEDOM Fracture-Healing Writing Group; Adachi JD, Bhandari M, de Gregorio L, Gilchrist N, Lyritis G, Moller G, Palacios S, Pavelka K, Heinrich R, Roux C, Uebelhart D. Denosumab treatment in postmenopausal women with osteoporosis does not interfere with fracture-healing: results from the FREEDOM trial. J Bone Joint Surg Am. 2012 Dec 5;94(23):2113-9. doi: 10.2106/JBJS.K.00774.
Background: PubMed 22095631Austin M, Yang YC, Vittinghoff E, Adami S, Boonen S, Bauer DC, Bianchi G, Bolognese MA, Christiansen C, Eastell R, Grauer A, Hawkins F, Kendler DL, Oliveri B, McClung MR, Reid IR, Siris ES, Zanchetta J, Zerbini CA, Libanati C, Cummings SR; FREEDOM Trial. Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures. J Bone Miner Res. 2012 Mar;27(3):687-93. doi: 10.1002/jbmr.1472.
Background: PubMed 22521543Bolognese MA, Teglbjaerg CS, Zanchetta JR, Lippuner K, McClung MR, Brandi ML, Hoiseth A, Lakatos P, Moffett AH, Lorenc RS, Wang A, Libanati C. Denosumab significantly increases DXA BMD at both trabecular and cortical sites: results from the FREEDOM study. J Clin Densitom. 2013 Apr-Jun;16(2):147-53. doi: 10.1016/j.jocd.2012.02.006. Epub 2012 Apr 20.
Background: PubMed 21411557Boonen S, Adachi JD, Man Z, Cummings SR, Lippuner K, Torring O, Gallagher JC, Farrerons J, Wang A, Franchimont N, San Martin J, Grauer A, McClung M. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab. 2011 Jun;96(6):1727-36. doi: 10.1210/jc.2010-2784. Epub 2011 Mar 16.
Background: PubMed 23109251Brown JP, Roux C, Torring O, Ho PR, Beck Jensen JE, Gilchrist N, Recknor C, Austin M, Wang A, Grauer A, Wagman RB. Discontinuation of denosumab and associated fracture incidence: analysis from the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial. J Bone Miner Res. 2013 Apr;28(4):746-52. doi: 10.1002/jbmr.1808.
Background: PubMed 19671655Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11.
Background: PubMed 20839290Eastell R, Christiansen C, Grauer A, Kutilek S, Libanati C, McClung MR, Reid IR, Resch H, Siris E, Uebelhart D, Wang A, Weryha G, Cummings SR. Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):530-7. doi: 10.1002/jbmr.251.
Background: PubMed 22832638Freemantle N, Cooper C, Diez-Perez A, Gitlin M, Radcliffe H, Shepherd S, Roux C. Results of indirect and mixed treatment comparison of fracture efficacy for osteoporosis treatments: a meta-analysis. Osteoporos Int. 2013 Jan;24(1):209-17. doi: 10.1007/s00198-012-2068-9. Epub 2012 Jul 26.
Background: PubMed 23871852Genant HK, Libanati C, Engelke K, Zanchetta JR, Hoiseth A, Yuen CK, Stonkus S, Bolognese MA, Franek E, Fuerst T, Radcliffe HS, McClung MR. Improvements in hip trabecular, subcortical, and cortical density and mass in postmenopausal women with osteoporosis treated with denosumab. Bone. 2013 Oct;56(2):482-8. doi: 10.1016/j.bone.2013.07.011. Epub 2013 Jul 17.
BackgroundHadji P, Bock O, Resch H, Kraenzlin M, Wang A, Steinle T, Eisen C. Reduction of fracture risk with denosumab among women with osteoporosis with or without need for treatment according to DVO 2009 guideline : A subgroup analysis of the FREEDOM trial. Osteologie. 2013;22(1):39-45.
Background: PubMed 21491487Jamal SA, Ljunggren O, Stehman-Breen C, Cummings SR, McClung MR, Goemaere S, Ebeling PR, Franek E, Yang YC, Egbuna OI, Boonen S, Miller PD. Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res. 2011 Aug;26(8):1829-35. doi: 10.1002/jbmr.403.
Background: PubMed 23794225Keaveny TM, McClung MR, Genant HK, Zanchetta JR, Kendler D, Brown JP, Goemaere S, Recknor C, Brandi ML, Eastell R, Kopperdahl DL, Engelke K, Fuerst T, Radcliffe HS, Libanati C. Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab. J Bone Miner Res. 2014 Jan;29(1):158-65. doi: 10.1002/jbmr.2024.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denosumab in people with Osteoporosis, run by Amgen.

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 2 inclusion and 2 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 8 Nov 2022. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With New Vertebral Fractures (time frame: 36 months). 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 NCT00089791, which also lists 33 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 8 Nov 2022.