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Not yet recruitingNCT07909304Updated Nov 3, 2026

Romosozumab and Denosumab Combination Therapy for Osteoporosis

A Phase 4 interventional study of Romosozumab and Romosozumab and Denosumab in Postmenopausal Osteoporosis, sponsored by Massachusetts General Hospital. Not yet recruiting. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment

Updated Nov 3, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years and older
Sex
Female
01

Study summary

In this research study, the investigators want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

02

Conditions studied

  • Postmenopausal Osteoporosis
03

In context

Osteoporosis, Postmenopausal

339 studies on the registry are indexed under Osteoporosis, Postmenopausal; 30 are open to participants now.

This study's planned enrollment of 100 is close to the median of 110 across 266 interventional studies indexed under Osteoporosis, Postmenopausal.

Browse Osteoporosis, Postmenopausal studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,584 studies on the registry; 448 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Browse Massachusetts General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women age > 45
  • Postmenopausal by either of the following criteria: (1) > 36 months since last spontaneous menses; or (2) > 36 months since hysterectomy, plus serum FSH > 40 units / liter if \< 60 years
  • High risk of fracture defined as one of the following: (1) Prior history of osteoporotic fracture, plus hip or spine BMD T-score \< -2.0; (2) Hip or spine BMD T-score \< -2.5; or (3) 10-year predicted fracture risk of ≥20% for major osteoporotic fracture or ≥3% for hip fracture (designated as "high risk of fracture" by osteoporosis guidelines)

Exclusion criteria

Exclusion Criteria:

  • Current or past use in the 12 months of denosumab
  • Any prior exposure to romosozumab
  • Current or use in the past 3 months of estrogens or SERMs
  • Current or use in the past 6 months of oral bisphosphonates (BPs) if most recent duration of oral BP use is less than 3 years; or current or use in the past 12 months of oral BPs if most recent duration of oral BP use is 3 years or more
  • Current or use in the past 36 months of parenteral BPs
  • Current or use in the past 24 months of teriparatide or abaloparatide
  • Use of glucocorticoids for more than 14 days consecutively within the past 6 months
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Romosozumab and denosumab

    Drug: Romosozumab and Denosumab

  • Active comparator
    Romosozumab

    Drug: Romosozumab

Interventions

  • DrugRomosozumab

    Monthly romosozumab

  • DrugRomosozumab and Denosumab

    Monthly romosozumab, Every 6 months denosumab

06

What researchers measure

Primary outcomes

  1. Total hip areal bone mineral density

    Change in total hip bone density between month 0 and month 12

    Time frame: Month 0 to 12

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Leder BZ, Ramchand SK, Jordan M, Ryan S, Patnaik A, Lee H, Tsai JN. 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Mar;14(3):216-222. doi: 10.1016/S2213-8587(25)00319-5. Epub 2026 Jan 29. PubMed 41621431 ↗
  • Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet. 2013 Jul 6;382(9886):50-6. doi: 10.1016/S0140-6736(13)60856-9. Epub 2013 May 15. PubMed 23683600 ↗

Individual participant data

Plan to share: Yes

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Dec 2030, 47 months later.

Of 26 phase 4 interventional studies under Osteoporosis, Postmenopausal, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 66. This study's planned 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartEst.
Jan 2027
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
2 inclusion criteria edited, 2 removed
What changed in the criteria
Inclusion criteria
  • RemovedPostmenopausal by either of the following criteria:
  • EditedPostmenopausal by either of the following criteria: (1) > 36 months since last spontaneous menses; or (2) > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years
  • RemovedHigh risk of fracture defined as one of the following:
  • EditedHigh risk of fracture defined as one of the following: (1) Prior history of osteoporotic fracture, plus hip or spine BMD T-score < -2.0; (2) Hip or spine BMD T-score < -2.5; or (3) 10-year predicted fracture risk of ≥20% for major osteoporotic fracture or ≥3% for hip fracture (designated as "high risk of fracture" by osteoporosis guidelines)
Nov 3, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 3, 2026
    Eligibility 2 inclusion criteria edited, 2 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedPostmenopausal by either of the following criteria:
    • EditedPostmenopausal by either of the following criteria: (1) > 36 months since last spontaneous menses; or (2) > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years
    • RemovedHigh risk of fracture defined as one of the following:
    • EditedHigh risk of fracture defined as one of the following: (1) Prior history of osteoporotic fracture, plus hip or spine BMD T-score < -2.0; (2) Hip or spine BMD T-score < -2.5; or (3) 10-year predicted fracture risk of ≥20% for major osteoporotic fracture or ≥3% for hip fracture (designated as "high risk of fracture" by osteoporosis guidelines)
    + 1 other change: description
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07909304
Lead sponsor
Massachusetts General Hospital
Responsible party
Elaine W. Yu (Associate Professor, Massachusetts General Hospital) — Principal investigator
First posted
Nov 2, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Elaine W Yu
Contact
EWYU@mgh.harvard.edu
617-643-6353

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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