Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02176382
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis	Drug: denosumab; Drug: teriparatide; Drug: Zoledronic acid	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard dose teriparatide teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15	Drug: denosumab; denosumab subcutaneous injection; Other Names: Prolia ; Drug: teriparatide; teriparatide daily subcutaneous injection; Other Names: Forteo ; Drug: Zoledronic acid; zoledronic acid infusion; Other Names: Reclast
Active Comparator: High dose teriparatide teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15	Drug: denosumab; denosumab subcutaneous injection; Other Names: Prolia ; Drug: teriparatide; teriparatide daily subcutaneous injection; Other Names: Forteo ; Drug: Zoledronic acid; zoledronic acid infusion; Other Names: Reclast

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) [Baseline and 42 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women aged 45+

• postmenopausal

• osteoporotic with high risk of fracture

Exclusion Criteria:

• no significant previous use of bone health modifying treatments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Benjamin Leder, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 25, 2019

More Information

Publications

• Ramchand SK, David NL, Leder BZ, Tsai JN. Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT. J Clin Endocrinol Metab. 2020 Mar 1;105(3). pii: dgz163. doi: 10.1210/clinem/dgz163.
• Ramchand SK, David NL, Lee H, Bruce M, Bouxsein ML, Leder BZ, Tsai JN. Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: The DATA-HD HR-pQCT Study. J Bone Miner Res. 2021 Jan;36(1):41-51. doi: 10.1002/jbmr.4161. Epub 2020 Sep 19.

• Responsible Party: Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02176382
• Other Study ID Numbers: 2014P000853
• First Posted: Jun 27, 2014
• Last Update Posted: Feb 9, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Zoledronic Acid; Denosumab; Teriparatide

Study Results

Participant Flow

Arm/Group Title	Standard Dose Teriparatide	High Dose Teriparatide
Arm/Group Description	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion	teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion
Period Title: DATA-HD Study
STARTED	39	37
COMPLETED	31	29
NOT COMPLETED	8	8
Period Title: DATA-HD Study
STARTED	27	26
COMPLETED	26	26
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Standard Dose Teriparatide	High Dose Teriparatide	Total
Arm/Group Description	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion	teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion	Total of all reporting groups
Overall Participants	35	34	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (7.0)	67.0 (7.3)	66.4 (7.1)
Sex: Female, Male (Count of Participants)
Female	35 100%	34 100%	69 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.9%	1 2.9%	2 2.9%
Not Hispanic or Latino	34 97.1%	33 97.1%	67 97.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 2.9%	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 5.7%	0 0%	2 2.9%
White	33 94.3%	33 97.1%	66 95.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
Time Frame	Baseline and 42 months

Outcome Measure Data

Analysis Population Description

Population includes those who completed a month 42 visit.

Arm/Group Title	Standard Dose Teriparatide	High Dose Teriparatide
Arm/Group Description	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion	teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion
Measure Participants	26	26
Mean (Standard Deviation) [percent change in BMD]	7.69 (4.66)	12.70 (5.54)

Adverse Events

Time Frame	3.5 years
Arm/Group Title	Standard Dose Teriparatide		High Dose Teriparatide
Arm/Group Description	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion		teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion
All Cause Mortality
	Standard Dose Teriparatide		High Dose Teriparatide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/37 (0%)
Serious Adverse Events
	Standard Dose Teriparatide		High Dose Teriparatide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/39 (23.1%)		2/37 (5.4%)
Endocrine disorders
pancreatitis	1/39 (2.6%)		0/37 (0%)
Musculoskeletal and connective tissue disorders
wrist fracture	2/39 (5.1%)		1/37 (2.7%)
clavicle fracture	1/39 (2.6%)		0/37 (0%)
fibula avulsion fracture	1/39 (2.6%)		0/37 (0%)
humeral fracture	1/39 (2.6%)		0/37 (0%)
rib fracture	1/39 (2.6%)		0/37 (0%)
shoulder dislocation	1/39 (2.6%)		0/37 (0%)
vertebral fracture	1/39 (2.6%)		0/37 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
anal cancer	0/39 (0%)		1/37 (2.7%)
breast cancer	2/39 (5.1%)		0/37 (0%)
kidney cancer	1/39 (2.6%)		0/37 (0%)
throat cancer	1/39 (2.6%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Standard Dose Teriparatide		High Dose Teriparatide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		2/37 (5.4%)
Musculoskeletal and connective tissue disorders
back pain	0/39 (0%)		2/37 (5.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.